FAMILY DOLLAR DAYTIME AND NIGHTTIME COMBO PACK COLD AND FLU- acetaminophen, dextromethorphan hbr, phenylephrine hydrochloride, and doxylamine succinate 
FAMILY DOLLAR SERVICES INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Family Dollar Daytime & Nighttime Combo Pack Cold & Flu

FAMILY DOLLAR DAYTIME COLD & FLU RELIEF

Active ingredients (in each 15 mL)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant

Uses

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

Warnings

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. 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.

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

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

FAMILY DOLLAR NIGHTTIME COLD & FLU RELIEF

Active ingredients (in each 30 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant
Antihistamine

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. 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.

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 information

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

Inactive ingredients

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?

1-866-467-2748

Distributed By:

PRINCIPAL DISPLAY PANEL - Kit Carton

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.

Family Dollar Daytime and NightTime Cold And Flu relief 472 mL (COMBO PACK)
FAMILY DOLLAR DAYTIME AND NIGHTTIME COMBO PACK  COLD AND FLU
acetaminophen, dextromethorphan hbr, phenylephrine hydrochloride, and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-808
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-808-161 in 1 PACKAGE; Type 0: Not a Combination Product08/21/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 236 mL
Part 21 BOTTLE 236 mL
Part 1 of 2
FD DAYTIME COLD AND FLU  RELIEF
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
Product Information
Item Code (Source)NDC:55319-036
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-036-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/21/2023
Part 2 of 2
FD NIGHTTIME COLD AND FLU  RELIEF
acetaminophen, doxylamine succinate, and dextromethorphan hydrobromide liquid
Product Information
Item Code (Source)NDC:55319-096
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-096-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/21/2023
Labeler - FAMILY DOLLAR SERVICES INC (024472631)

Revised: 9/2023
Document Id: 8baef60a-6aee-4e13-b2c8-e52aa6dffba5
Set id: 8baef60a-6aee-4e13-b2c8-e52aa6dffba5
Version: 1
Effective Time: 20230908
 
FAMILY DOLLAR SERVICES INC