COLD AND FLU NON DROWSY DAYTIME AND NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride 
Meijer, Inc.

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Cold and Flu Non Drowsy Daytime and Nighttime

Active ingredients (in each softgel)

COLD & FLU NON-DROWSY DAY RELIEF 

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

COLD & FLU NIGHT RELIEF

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Purposes

COLD & FLU NON DROWSY DAY RELIEF

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

COLD & FLU NIGHT RELIEF

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

Warnings

Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: ● more than 4 doses 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, persists 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.● if you have ever had an allergic reaction to this product or any of its ingredients● to make a child sleepy (Nighttime only)

Ask a doctor before use if you have

● cough that occurs with too much phlegm (mucus) ● liver disease
● trouble urinating due to enlarged prostate gland
● diabetes (Daytime only) ● heart disease (Daytime only)
● thyroid disease (Daytime only) ● high blood pressure (Daytime only)
● persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
● a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
● glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers (Nighttime only)

When using this product

● do not take more than directed
● marked drowsiness may occur (Nighttime only)
● avoid alcoholic drinks (Nighttime only)
● excitability may occur, especially in children (Nighttime only)
● be careful when driving a motor vehicle or operating machinery (Nighttime only)
● alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

Stop use and ask a doctor if

● you get nervous, dizzy or sleepless (Daytime only)
● pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
● pain or cough gets worse or lasts more than 7 days (Nighttime only)
● 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 Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

● when using other DAYTIME and NIGHTTIME products, carefully read each
label to ensure correct dosing

Directions (Daytime only)
● take only as directed - see Overdose warning
● do not exceed 4 doses per 24 hours

adults & children 12 years & overtake 2 softgels with water every 4 hours
children 4 to under 12 yearsask a doctor
children under 4 years of agedo not use

 ● when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing

Directions (Nighttime only)

● take only as directed - see Overdose warning
● do not exceed 4 doses per 24 hours

adults & children 12 years & overtake 2 softgels with water every 6 hours
children 4 to under 12 yearsask a doctor
children under 4 years of agedo not use

Other information

Inactive ingredients

DAY RELIEF

FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, myglyol, lecithin, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide 

NIGHT RELIEF

D&C Yellow# 10, FD&C Blue# 1, gelatin, glycerin, myglyol, lecithin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, polysorb, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

Principal Display Panel

Carton

COLD AND FLU NON DROWSY DAYTIME AND NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0030
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79481-0030-41 in 1 CARTON; Type 1: Convenience Kit of Co-Package09/19/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 BLISTER PACK 32 
Part 22 BLISTER PACK 16 
Part 1 of 2
COLD AND FLU NON DROWSY DAY RELIEF 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Item Code (Source)NDC:79481-0028
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize21mm
FlavorImprint Code 512;A09;AP01
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 CARTON
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/19/2022
Part 2 of 2
COLD AND FLU NIGHT RELIEF 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Item Code (Source)NDC:79481-0029
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize21mm
FlavorImprint Code 116;A07;AP02
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 CARTON
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/19/2022
Labeler - Meijer, Inc. (006959555)

Revised: 12/2023
Document Id: 0c068849-08ed-ca22-e063-6394a90ac04d
Set id: ce7e397d-a57d-4ae7-94f5-e1c4dfe25ca3
Version: 5
Effective Time: 20231208
 
Meijer, Inc.