meijer daytime and nighttime cold & flu softgel

meijer daytime and nighttime cold & flu softgel
SPL v1
SPL
SPL Set ID 6dd4e789-371b-4f10-aab0-94362a3d0bdd
Route
oral
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) phenylephrine (5 mg) doxylamine (15 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 d&c yellow no. 10 fd&c blue no. 1

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2024-06-27

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Drug Facts


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, 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

• high blood pressure

• thyroid disease • diabetes

• trouble urinating due to enlarged prostate gland

• cough that occurs with too much phlegm (mucus)

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

Uses

temporarily relieves common cold/flu symptoms:

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

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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

Description

Drug Facts

Section 42229-5

COMBO PACK

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

RELIEVES HEADACHE, FEVER, SORE THROAT, COUGH, NASAL CONGESTION

ANTIHISTAMINE FREE

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

RELIEVES HEADACHE, FEVER, SORE THROAT, COUGH, RUNNY NOSE, SNEEZING

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.

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

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

WWW.MEIJER.COM

PRODUCT OF UNITED ARAB EMIRATES

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

Questions Or Comments?

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

Meijer Daytime Cold & Flu Softgel

Drug Facts

Meijer Nighttime Cold & Flu Softgel

Drug Facts

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 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, 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

• high blood pressure

• thyroid disease • diabetes

• trouble urinating due to enlarged prostate gland

• cough that occurs with too much phlegm (mucus)

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

Uses

temporarily relieves common cold/flu symptoms:

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

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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 (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

Section 42229-5 (42229-5)

COMBO PACK

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

RELIEVES HEADACHE, FEVER, SORE THROAT, COUGH, NASAL CONGESTION

ANTIHISTAMINE FREE

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

RELIEVES HEADACHE, FEVER, SORE THROAT, COUGH, RUNNY NOSE, SNEEZING

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.

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

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

WWW.MEIJER.COM

PRODUCT OF UNITED ARAB EMIRATES

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

Questions Or Comments? (Questions or comments?)

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

Meijer Daytime Cold & Flu Softgel (meijer Daytime Cold & Flu SOFTGEL)

Drug Facts

Meijer Nighttime Cold & Flu Softgel (meijer Nighttime Cold & Flu SOFTGEL)

Drug Facts

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)