Family Dollar Daytime & Nighttime Combo Pack Cold & Flu

Family Dollar Daytime & Nighttime Combo Pack Cold & Flu
SPL v1
SPL
SPL Set ID 8baef60a-6aee-4e13-b2c8-e52aa6dffba5
Route
ORAL
Published
Effective Date 2023-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (650 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Yellow No. 6 Glycerin Menthol, Unspecified Form Potassium Citrate Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum D&c Yellow No. 10 Fd&c Green No. 3 Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-08-21

Description

FAMILY DOLLAR DAYTIME COLD & FLU RELIEF

Purpose

Pain reliever/Fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Description

FAMILY DOLLAR DAYTIME COLD & FLU RELIEF

Uses
  •  
    temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
Section 42229-5

FAMILY DOLLAR DAYTIME COLD & FLU RELIEF

Section 50565-1

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.

Section 53414-9

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

Questions?

1-866-467-2748

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

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

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.


Structured Label Content

Uses
  •  
    temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
Section 42229-5 (42229-5)

FAMILY DOLLAR DAYTIME COLD & FLU RELIEF

Section 50565-1 (50565-1)

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.

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

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

Questions?

1-866-467-2748

Other Information (Other information)

each 15 mL contains:

  • sodium 42 mg
  • store at room temperature
  • Do not refrigerate.
Inactive Ingredients (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

Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Principal Display Panel Kit Carton (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)