MULTI-SYMPTOM NIGHTTIME COLD & FLU

Set ID
23848c55-c9f8-44ef-bc98-a1a7483356a9
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:42:44

Key Label Information

Uses

Uses

temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches/pains fever runny nose and sneezing

Warnings

Warnings

Directions And Dosage

Directions

Take only as recommended—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 6 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use If taking Nighttime and Daytime 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

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, lecithin, myglyol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Nighttime Multi-symptom Cold & Flu Acetaminophen - Pain Reliever / Fever Reducer Dextromethorphan HBr - Cough Suppressant Doxylamine Succinate - Antihistamine Relief of: • Headache & Fever • Sore Throat • Minor Aches & Pains • Cough • Sneezing & Runny Nose 10 Softgels

Products

NDC Codes

Ingredients

NameUNIIKind
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches/pains fever runny nose and sneezing

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Take only as recommended—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 6 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use If taking Nighttime and Daytime 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

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, lecithin, myglyol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nighttime Multi-symptom Cold & Flu Acetaminophen - Pain Reliever / Fever Reducer Dextromethorphan HBr - Cough Suppressant Doxylamine Succinate - Antihistamine Relief of: • Headache & Fever • Sore Throat • Minor Aches & Pains • Cough • Sneezing & Runny Nose 10 Softgels

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
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Legacy File Index

FolderFileDate
otc292bbbca-540e-eb19-e063-6394a90a4251.xml2024-12-15
otc0bf2ddb2-5d63-1839-e063-6294a90ad075.xml2023-12-08
otcef57f78c-d58a-a306-e053-2a95a90af3f5.xml2022-12-11
otcValuHealth NightTime Softgels.jpg2022-12-11