BASIC CARE DAYTIME NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phen

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
L. Perrigo Company
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant temporarily relieves common cold/flu symptoms: Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant temporarily relieves common cold/flu symptoms: taking the blood thinning drug warfarin
Authorization status:
OTC monograph final
Authorization number:
0113-7597-02, 0113-7603-40, 0113-7763-40

BASIC CARE DAYTIME NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan

hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride

L. Perrigo Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Amazon Daytime Nighttime Cold & Flu Drug Facts

Nighttime Severe Cold & Flu

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Purpos e

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Us es

temporarily relieves common cold/flu symptoms:

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

nasal congestion

sinus congestion and pressure

minor aches and pains

headache

fever

sore throat

runny nose and sneezing

cough due to minor throat and bronchial irritation

cough to help you sleep

reduces swelling of nasal passages

promotes nasal and/or sinus drainage

temporarily restores freer breathing through the nose

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or

followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

3 or more alcoholic drinks every day while using this product

skin reddening

blisters

rash

with any other drug containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after

stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a

doctor or pharmacist before taking this product.

if you have ever had an allergic reaction to this product or any of its ingredients

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

glaucoma

cough that occurs with too much phlegm (mucus)

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

persistent or chronic cough such as occurs with smoking, asthma, or emphysema

a sodium-restricted diet

taking sedatives or tranquilizers

taking the blood thinning drug warfarin

do not use more than directed

excitability may occur, especially in children

marked drowsiness may occur

avoid alcoholic drinks

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right

away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you

do not notice any signs or symptoms.

Directions

adults & children 12 yrs & over

30 mL every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene

glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol

solution, sucralose, xanthan gum

Questions or comments?

1-800-719-9260

be careful when driving a motor vehicle or operating machinery

alcohol, sedatives, and tranquilizers may increase drowsiness

you get nervous, dizzy or sleepless

pain, nasal congestion, or cough gets worse or lasts more than 7 days

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

cough comes back or occurs with rash or headache that lasts. These could be signs of a serious

condition.

take only as directed - see Overdose warning

only use the dose cup provided

do not exceed 4 doses per 24 hrs

each 30 mL contains: sodium 41 mg

store at 20-25 C (68-77 F)

Daytime Severe Cold & Flu

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpos e

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Us es

temporarily relieves common cold/flu symptoms:

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

nasal congestion

sinus congestion and pressure

cough due to minor throat and bronchial irritation

minor aches and pains

headache

fever

sore throat

reduces swelling of nasal passages

temporarily restores freer breathing through the nose

promotes nasal and/or sinus drainage

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of

bothersome mucus and make coughs more productive

adult takes more than 4,000 mg of acetaminophen in 24 hours

child takes more than 5 doses in 24 hours

taken with other drugs containing acetaminophen

adult has 3 or more alcoholic drinks every day while using this product

skin reddening

blisters

rash

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or

followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

with any other drug containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after

stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a

doctor or pharmacist before taking this product.

if you have ever had an allergic reaction to this product or any of its ingredients

liver disease

heart disease

thyroid disease

diabetes

high blood pressure

trouble urinating due to an enlarged prostate gland

cough that occurs with too much phlegm (mucus)

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or

emphysema

you get nervous, dizzy or sleepless

pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

cough comes back or occurs with rash or headache that lasts. These could be signs of a serious

condition.

Overdose warning: In care of overdose, get medical help or contact a Poison Control Center right

away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you

do not notice any signs or symptoms.

Directions

adults & children 12 yrs & over

30 mL every 4 hrs

children 6 to under 12 yrs

15 mL every 4 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use

Other information

Inactive ingredients

butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic

sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose,

xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Combo Pack!

Maximum Strength

Compare to Vicks

DayQuil

Severe Cold & Flu active ingredients

Non-Drowsy

daytime cold & flu severe

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

Pain Reliever, Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant

Alcohol Free

Original Flavor

12 FL OZ (355 mL)

Maximum Strength

Compare to Vicks

NyQuil

Severe Cold & Flu active ingredients

nighttime cold & flu severe

take only as directed - see Overdose warning

only use the dose cup provided

do not exceed 4 doses per 24 hrs

each 15 mL contains: sodium 6 mg

store at 20-25 C (68-77 F). Do not refrigerate.

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

Nasal Decongestant

Alcohol Free

Berry Flavor

12 FL OZ (355 mL)

BASIC CARE DAYTIME NIGHTTIME COLD AND FLU

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 113-759 7

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 113-759 7-0 2

1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

0 3/14/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE

355 mL

Pa rt 2

1 BOTTLE

355 mL

Part 1 of 2

BASIC CARE NIGHTTIME COLD AND FLU SEVERE

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride solution

Product Information

Ite m Code (Source )

NDC:0 113-776 3

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

6 50 mg

in 30 mL

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

20 mg

in 30 mL

DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE -

UNII:9 5QB77JKPL)

DOXYLAMINE SUCCINATE

12.5 mg

in 30 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

RED (clear)

S core

S hap e

S iz e

Flavor

BERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 113-776 3-40

355 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

Part 2 of 2

BASIC CARE DAYTIME COLD AND FLU SEVERE

acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information

Ite m Code (Source )

NDC:0 113-76 0 3

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

in 15 mL

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

in 15 mL

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

20 0 mg

in 15 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

PHENYLEPHRINE

5 mg

L. Perrigo Company

UNII:1WS29 7W6 MV)

HYDROCHLORIDE

in 15 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

GLYCERIN (UNII: PDC6 A3C0 OX)

MENTHO L (UNII: L7T10 EIP3A)

SO DIUM PHO SPHATE, MO NO BASIC (UNII: 39 8 0 JIH2SW)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SUCRO SE (UNII: C151H8 M554)

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

ORANGE (clear)

S core

S hap e

S iz e

Flavor

FRUIT, MENTHOL

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 113-76 0 3-40

355 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 3/14/20 19

Labeler -

L. Perrigo Company (006013346)

Revised: 5/2019

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