DAYTIME COLD AND FLU NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochlor

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:
Meijer, Inc.
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Authorization status:
OTC monograph final
Authorization number:
41250-448-90

DAYTIME COLD AND FLU NIGHTTIME COLD AND FLU- acetaminophen,

dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine

succinate

Meijer, Inc.

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.

----------

Meijer Distribution, Inc. Daytime Cold & Flu Nighttime Cold & Flu Drug Facts

Active ingredients (in each liquid gel) DAY Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes DAY Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Active ingredients (in each liquid gel) NIGHT Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purposes NIGHT Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Us es

temporarily relieves these common cold and flu symptoms:

sinus congestion and pressure

cough

minor aches and pains

headache

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

nasal congestion

sore throat

runny nose (NIGHT only)

sneezing (NIGHT only)

itching of the nose or throat (NIGHT only)

itchy, watery eyes due to hay fever (NIGHT only)

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

bothersome mucus and make coughs more productive (DAY only)

controls cough to help you get to sleep

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.

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

diabetes

high blood pressure

thyroid disease

trouble urinating due to an enlarged prostate gland

glaucoma (NIGHT only)

a breathing problem such as emphysema or chronic bronchitis (NIGHT only)

Ask a doctor or pharmacist before use if you are

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

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

emphysema

cough that occurs with too much phlegm (mucus)

taking the blood thinning drug warfarin

taking sedatives or tranquilizers (NIGHT only)

do not use more than directed

excitability may occur, especially in children (NIGHT only)

marked drowsiness may occur (NIGHT only)

alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)

avoid alcoholic drinks (NIGHT only)

be careful when driving a motor vehicle or operating machinery (NIGHT 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.

do not take more than directed (see Overdose warning)

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

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

children under 12 years of age: do not use

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

Inactive ingredients (DAY only)

edible ink*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone,

propylene glycol, purified water, sorbitol sorbitan solution

*may contain this ingredient

Inactive ingredients (NIGHT only)

D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone,

propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

COMBO PACK

Compare to Mucinex

Fast-Max

Day Cold & Flu active ingredients

Ages 12+

MAXIMUM STRENGTH

daytime cold & flu

Acetaminophen

Pain Reliever | Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Guaifenesin

Expectorant

Phenylephrine HCl

Nasal Decongestant

ALL IN ONE RELIEF

16 Liquid Gels (Liquid Filled Capsules)

Sore Throat, Fever, Chest Congestion, Cough, Nasal Congestion, Sinus Congestion, Sinus Pressure,

Headache, Body Pain

actual size

Compare to Mucinex

Fast-Max

Night Cold & Flu active ingredients

Ages 12+

MAXIMUM STRENGTH

nighttime cold & flu

Acetaminophen

Pain Reliever | Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Doxylamine Succinate

Antihistamine

Phenylephrine HCl

Nasal Decongestant

ALL IN ONE RELIEF

8 Liquid Gels (liquid Filled Capsules)

Sore Throat, Fever, Itchy Throat, Cough, Nasal Congestion, Sneezing, Runny Nose, Headache, Body

Pain

actual size

DAYTIME COLD AND FLU NIGHTTIME COLD AND FLU

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

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -448

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -448 -9 0

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

0 7/24/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

8 BLISTER PACK

Pa rt 2

4 BLISTER PACK

Part 1 of 2

DAYTIME COLD AND FLU

acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled

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

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

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

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

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

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

WATER (UNII: 0 59 QF0 KO0 R)

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

SO RBITAN (UNII: 6 O9 2ICV9 RU)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

OVAL

S iz e

25mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

8 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

NIGHTTIME COLD AND FLU

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

liquid filled

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

Meijer, Inc.

DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE - UNII:9 5QB77JKPL)

DOXYLAMINE SUCCINATE

6 .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

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

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

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

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

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

WATER (UNII: 0 59 QF0 KO0 R)

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

SO RBITAN (UNII: 6 O9 2ICV9 RU)

Product Characteristics

Color

GREEN

S core

no sco re

S hap e

OVAL

S iz e

20 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

4 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

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 7/24/20 19

Labeler -

Meijer, Inc. (006959555)

Revised: 7/2019

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