Family Dollar Daytime and Nighttime Combo Pack

Manufacturer
FAMILY DOLLAR SERVICES INC
Effective date
2023-09-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:08

Key Label Information#

Active Ingredients And Purpose

Active ingredients (in each 15 mL)

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Active ingredients (in each 30 mL)

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Uses

Uses

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

Uses

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

Warnings

Warnings

Warnings

Directions And Dosage

Directions

• take only as directed • Only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hours Children 6 to under 12 yrs 15 mL every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Directions

• take only as directed • Only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Other Label Information

Other information

each 15 mL contains : • sodium 42 mg • store at room temperature • Do not refrigerate.

Inactive ingredients

Anhydrous citric acid, disodium edetate, FD&C Yellow No. 6, flavor, glycerin, menthol, potassium citrate, propyl gallate, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

Questions?

1-866-467-2748

Other information

• each 30 mL contains: sodium 16 mg • Store at room temperature • Do not refrigerate

Label Images#

48ct
48ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2637726{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } PackGPCK1
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) PackPSN1
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN1
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN1
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD1
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD1
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) PackSY1
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY1
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY1
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY1
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY1
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSY1
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-808-162025-01-30C16284748780-12cef2736-9f8d-d83d-e063-dadaa90ab31fFamily Dollar Daytime & Nighttime Combo Pack Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-036-08Family Dollar Daytime and Nighttime Combo PackCold and Flu236 mL in 1 BOTTLELIQUID236 mL5 mg in 15mL1
55319-096-08Family Dollar Daytime and Nighttime Combo PackCold and Flu236 mL in 1 BOTTLELIQUID236 mL650 mg in 30mL1
55319-808-16Family Dollar Daytime and Nighttime Combo PackCold and Flu1 in 1 PACKAGEKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-036FAMILY DOLLAR DAYTIME AND NIGHTTIME COMBO PACK COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [FAMILY DOLLAR SERVICES INC]1Unmatched20230910_8baef60a-6aee-4e13-b2c8-e52aa6dffba5.zip
55319-096FAMILY DOLLAR DAYTIME AND NIGHTTIME COMBO PACK COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [FAMILY DOLLAR SERVICES INC]1Unmatched20230910_8baef60a-6aee-4e13-b2c8-e52aa6dffba5.zip
55319-808FAMILY DOLLAR DAYTIME AND NIGHTTIME COMBO PACK COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [FAMILY DOLLAR SERVICES INC]13 package rows20230910_8baef60a-6aee-4e13-b2c8-e52aa6dffba5.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-80855319-808-16
55319-03655319-036-08
55319-09655319-096-08

Ingredients#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

FAMILY DOLLAR DAYTIME COLD & FLU RELIEF

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• take only as directed • Only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hours Children 6 to under 12 yrs 15 mL every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Other information

STORAGE AND HANDLING SECTION

each 15 mL contains : • sodium 42 mg • store at room temperature • Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anhydrous citric acid, disodium edetate, FD&C Yellow No. 6, flavor, glycerin, menthol, potassium citrate, propyl gallate, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-866-467-2748

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

FAMILY DOLLAR NIGHTTIME COLD & FLU RELIEF

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• take only as directed • Only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Other information

STORAGE AND HANDLING SECTION

• each 30 mL contains: sodium 16 mg • Store at room temperature • Do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No.3, FD&C Yellow no 6, flavor, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions?

OTC - QUESTIONS SECTION

1-866-467-2748

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Distributed By:

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Vicks®DayQuil™ & NyQuil™ Cold & Flu* NDC# 55319-808-16 DayTime Cold & Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl • Headache, Fever, Sore Throat, Minor Aches & Pains • Nasal Congestion & Sinus Pressure • Cough NightTime Cold & Flu Relief Acetaminophen, Dextromethorphan HBr Dextromethorphan HBr • headache, Fever, Sore Throat, Minor Aches & Pains Original Flavor TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN. 2 BOTTLES – 1 Daytime/1Nighttime; 8 FL OZ (236 mL) Each; TOTAL 16 FL OZ (472 mL) *These product is not manufactured or distributed by Procter & Gamble, distributor of Vicks®Dayquil™ & Nyquil™ Cold & flu.

Source Document#

Source XML