MEIJER DAYTIME COLD AND FLU SOFTGEL- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

meijer Daytime Cold and Flu SOFTGEL by

Drug Labeling and Warnings

meijer Daytime Cold and Flu SOFTGEL by is a Otc medication manufactured, distributed, or labeled by Meijer, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:
nasal congestion   cough due to minor throat & bronchial irritation  sore throat   headache  minor aches & pains   fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 softgels in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
skin reddening   blisters   rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
 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.

Ask a doctor before use if you have
liver disease heart disease diabetes
high blood pressure thyroid disease
trouble urinating due to enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough as occurs with smoking, asthma, or emphysema

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
 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.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

take only as directed
do not exceed 8 softgels per 24 hrs

• adults & children 12 yrs & over: 2 softgels with water every 4 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use

Other information

store at room temperature between 20°-25°C (68°-77°F)
protect from light, heat, and moisture

Inactive ingredients

edible printing ink, FD&C red no. 40, FD&C yellow no. 6, gelatin (bovine), glycerin, polyethylene glycol 400, povidone K-17, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST

SPL UNCLASSIFIED SECTION

COMPARE TO VICKS® DAYQUIL™ COLD & FLU LIQUICAPS™ ACTIVE INGREDIENTS*

ANTIHISTAMINE FREE

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the trademarks Vicks®, DayQuil™ and LiquiCaps™.

DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544

WWW.MEIJER.COM

PRODUCT OF UNITED ARAB EMIRATES

 READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Packaging

INGREDIENTS AND APPEARANCE

MEIJER DAYTIME COLD AND FLU SOFTGEL 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79481-0807
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN TYPE B BOVINE (230 BLOOM) (UNII: WIL1404U79)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K17 (UNII: C67P1734QJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	807
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79481-0807-4	2 in 1 CARTON	06/27/2024
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/27/2024

Labeler - Meijer, Inc. (006959555)