meijer nighttime cold & flu 

meijer nighttime cold & flu 
SPL v3
SPL
SPL Set ID 1bec5167-5fc5-2405-e063-6294a90a5358
Route
oral
Published
Effective Date 2024-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (15 mg) doxylamine (6.25 mg)
Inactive Ingredients
d&c yellow no. 10 fd&c blue no. 1 gelatin type b bovine (230 bloom) glycerin polyethylene glycol 400 povidone k17 propylene glycol water sorbitol sorbitan

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-27

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg


Medication Information

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, 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.

Ask a doctor before use if you have

• liver disease  • heart disease

• thyroid disease  • diabetes  • glaucoma

• cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

When using this product

 do not use more than directed

• excitability may occur, especially in children

• marked drowsiness may occur

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• pain, 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.

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation

• sore throat

• headache

• minor aches & pains

• fever

• runny nose & sneezing

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Directions

• take only as directed

• do not exceed 8 softgels per 24 hrs 

 adults & children 12 yrs & over  2 softgels with water every 6 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

D&C Yellow no. 10, edible printing ink, FD&C blue no. 1, gelatin (bovine), glycerin, polyethylene glycol 400, povidone K-17, propylene glycol, purified water, sorbitol sorbitan solution

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Section 42229-5

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

*This product is not manufactured or distributed by The Procter & Gamble Co., owner of the trademarks Vicks®, NyQuil™ 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.

Section 50565-1

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.

Packaging

Drug Facts

Questions Or Comments?

Monday - Friday 8am - 4pm EST

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


Structured Label Content

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, 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.

Ask a doctor before use if you have

• liver disease  • heart disease

• thyroid disease  • diabetes  • glaucoma

• cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

When using this product

 do not use more than directed

• excitability may occur, especially in children

• marked drowsiness may occur

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• pain, 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.

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation

• sore throat

• headache

• minor aches & pains

• fever

• runny nose & sneezing

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Directions

• take only as directed

• do not exceed 8 softgels per 24 hrs 

 adults & children 12 yrs & over  2 softgels with water every 6 hrs
 children 4 to under 12 yrs  ask a doctor
 children under 4 yrs  do not use

Other Information (Other information)

• store at room temperature between 20°-25°C (68°-77°F)

• protect from light, heat, and moisture

Inactive Ingredients (Inactive ingredients)

D&C Yellow no. 10, edible printing ink, FD&C blue no. 1, gelatin (bovine), glycerin, polyethylene glycol 400, povidone K-17, propylene glycol, purified water, sorbitol sorbitan solution

Section 42229-5 (42229-5)

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

*This product is not manufactured or distributed by The Procter & Gamble Co., owner of the trademarks Vicks®, NyQuil™ 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.

Section 50565-1 (50565-1)

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.

Packaging

Drug Facts

Questions Or Comments? (Questions or comments?)

Monday - Friday 8am - 4pm EST

Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)