Meijer Daytime Cold & Flu

Meijer Daytime Cold & Flu
SPL v2
SPL
SPL Set ID 1bdd7f8a-93ce-5309-e063-6294a90a91f0
Route
ORAL
Published
Effective Date 2024-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 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

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion  • cough due to minor throat & bronchial irritation  • sore throat  • headache  • minor aches & pains  • fever

Section 42229-5

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.

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.

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.

Packaging

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

Drug Facts

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

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion  • cough due to minor throat & bronchial irritation  • sore throat  • headache  • minor aches & pains  • fever

Section 42229-5 (42229-5)

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.

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.

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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.

Packaging

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

Drug Facts

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)

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? (Questions or comments?)

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

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

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)