625T KROGER 41226-625 MAX STRENGTH DAYTIME SEVERE COLD AND FLU

Set ID
9bb7aaf0-6698-9a5c-e053-2a95a90a097c
Manufacturer
KROGER COMPANY | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LTD
Effective date
2025-02-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:55:22

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation headache fever sore throat reduces swelling of the nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

WARNINGS SECTION

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 softgels in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

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 Label Information

INACTIVE INGREDIENT SECTION

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Products

NDC Codes

Ingredients

NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
GUAIFENESIN495W7451VQACTIB
ACETAMINOPHEN362O9ITL9DACTIB
SHELLAC46N107B71OIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT

Complete SPL Sections

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation headache fever sore throat reduces swelling of the nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

WARNINGS SECTION

WARNINGS SECTION

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 softgels in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

Other information do not exceed 25°C

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
31977

Legacy File Index

FolderFileDate
otc2e141369-9e32-7624-e063-6294a90a25f9.xml2025-02-16
otc625T-Kroger-24s-IFC.jpg2022-11-22
otcedfa3267-1612-1146-e053-2a95a90af44b.xml2022-11-22
otc625T 24 CT PDP.jpg2020-05-29
otca68d30d7-9711-cd56-e053-2a95a90a60de.xml2020-05-29