BASIC CARE DAYTIME SEVERE COLD NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine

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), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
L. Perrigo Company
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant Pain reliever/fever reducer Antihistamine Nasal decongestant
Authorization status:
OTC monograph final
Authorization number:
0113-7951-81

BASIC CARE DAYTIME SEVERE COLD NIGHTTIME COLD AND FLU- acetaminophen,

dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine

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 Day Time Severe Cold Night Time Cold & Flu Drug Facts

Active ingredients (in each caplet) - DAY TIME Severe Cold

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet) – NIGHT TIME Cold & Flu

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

Purposes - DAY TIME Severe Cold

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purposes - NIGHT TIME Cold & Flu

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Us es

temporarily relieves these common cold and flu symptoms:

nasal congestion

cough (DAY TIME Severe Cold only)

minor aches and pains

headache

sore throat

runny nose and sneezing (NIGHT TIME Cold & Flu only)

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

Warnings

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take

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

bothersome mucus and make coughs more productive (DAY TIME Severe Cold only)

temporarily reduces fever

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using these products

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.

with any other product containing diphenhydramine, even one used on skin (NIGHT TIME Cold &

Flu only)

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 these products.

if you have ever had an allergic reaction to these products or any of their ingredients

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

glaucoma (NIGHT TIME Cold & Flu only)

a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME Cold & Flu only)

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

emphysema (DAY TIME Severe Cold only)

cough that occurs with too much phlegm (mucus) (DAY TIME Severe Cold only)

When using these products

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

Other information

Inactive ingredients - DAY TIME Severe Cold

croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake,

taking the blood thinning drug warfarin

taking sedatives or tranquilizers (NIGHT TIME Cold & Flu only)

do not use more than directed

excitability may occur, especially in children (NIGHT TIME Cold & Flu only)

marked drowsiness may occur (NIGHT TIME Cold & Flu only)

alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME Cold & Flu only)

avoid alcoholic drinks (NIGHT TIME Cold & Flu only)

be careful when driving a motor vehicle or operating machinery (NIGHT TIME Cold & Flu only)

nervousness, dizziness, or sleeplessness occur

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. (DAY TIME Severe Cold only)

do not take more than directed (see Overdose warning)

do not take more than 10 caplets in any 24-hour period

adults and children 12 years of age and older: take 2 caplets every 4 hours

children under 12 years of age: do not use

each caplet contains: sodium 4 mg (DAY TIME Severe Cold only)

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

maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone,

pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Inactive ingredients – NIGHT TIME Cold & Flu

crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose,

polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid,

talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Mucinex

Fast-Max

Day Time & Night Time active ingredients

Maximum Strength

For Ages 12+

daytime severe cold

Acetaminophen

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Pain Reliever

Fever Reducer

Cough Suppressant

Expectorant

Nasal Decongestant

Relieves Aches, Fever & Sore Throat

Controls Cough

Relieves Nasal & Chest Congestion

Thins & Loosens Mucus

actual size

20 CAPLETS

For Ages 12+

night time cold & flu

Acetaminophen

Diphenhydramine HCl

Phenylephrine HCl

Pain Reliever

Fever Reducer

Antihistamine

Nasal Decongestant

Relieves Aches, Fever & Sore Throat

Relieves Nasal Congestion

Relieves Runny Nose & Sneezing

actual size

10 CAPLETS

BASIC CARE DAYTIME SEVERE COLD NIGHTTIME COLD AND FLU

acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine

hydrochloride kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 113-79 51

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 113-79 51-8 1

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

0 1/24/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

10 BLISTER PACK

Pa rt 2

5 BLISTER PACK

Part 1 of 2

BASIC CARE DAY TIME SEVERE COLD

acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated

Product Information

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

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

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

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

GUAIFENESIN

20 0 mg

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

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

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

S core

no sco re

S hap e

OVAL

S iz e

20 mm

Flavor

Imprint Code

L9 22

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

10 in 1 CARTON

1

2 in 1 BLISTER PACK; 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 NIGHT TIME COLD AND FLU

acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride tablet, film coated

Product Information

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

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

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

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

BLUE

S core

no sco re

S hap e

OVAL

S iz e

16 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

5 in 1 CARTON

1

2 in 1 BLISTER PACK; 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

L. Perrigo Company

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 1/24/20 19

Labeler -

L. Perrigo Company (006013346)

Revised: 5/2019

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