VALUMEDS DAY TIME COLD & FLU MULTI-SYMPTOM RELIEF

Set ID
07b2e805-e837-42a0-9d79-5cd06ea58506
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:42:40

Key Label Information

Uses

Uses

temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches/pains fever

Warnings

Warnings

Directions And Dosage

Directions

Take only as directed—see Overdose warning . do not exceed 4 doses per 24 hours. adults and children 12 years of age and over swallow 2 softgels with water every 4 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use If taking Daytime and Nighttime softgels carefully read each label to insure correct dosing

Other Label Information

Other information

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat this product does not contain phenylpropanolamine

Inactive ingredients

FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL - 48 Softgels Blister Pack Carton

SEE NEW WARNINGS INFORMATION COMPARE TO ACTIVE INGREDIENTS IN VICKS ® DAYQUIL ® * VALUMEDS ™ NON-DROWSY DAY TIME COLD & FLU MULTI-SYMPTOM RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl Pain Reliever Fever Reducer Cough Suppressant Nasal Decongestant 48 SOFTGELS Liquid filled capsules

Products

NDC Codes

Ingredients

NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches/pains fever

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Take only as directed—see Overdose warning . do not exceed 4 doses per 24 hours. adults and children 12 years of age and over swallow 2 softgels with water every 4 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use If taking Daytime and Nighttime softgels carefully read each label to insure correct dosing

Other information

STORAGE AND HANDLING SECTION

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat this product does not contain phenylpropanolamine

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

PRINCIPAL DISPLAY PANEL - 48 Softgels Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEE NEW WARNINGS INFORMATION COMPARE TO ACTIVE INGREDIENTS IN VICKS ® DAYQUIL ® * VALUMEDS ™ NON-DROWSY DAY TIME COLD & FLU MULTI-SYMPTOM RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl Pain Reliever Fever Reducer Cough Suppressant Nasal Decongestant 48 SOFTGELS Liquid filled capsules

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc292c7184-1dbc-9085-e063-6294a90a16a3.xml2024-12-15
otc0c054670-1e47-d10b-e063-6294a90a7014.xml2023-12-09
otcee50efee-2a4f-4753-e053-2995a90af302.xml2022-11-26
otcd070f686-4cbc-55d1-e053-2995a90af638.xml2021-11-11
otcb60bc195-65f1-7032-e053-2995a90a6586.xml2020-12-10
otc9aa3c692-fbb0-debe-e053-2995a90add50.xml2019-12-27
otc48 Softgels Blister Pack Carton.jpg2018-04-18
otc6a24e396-682d-e01a-e053-2991aa0a04c2.xml2018-04-18