SPL v6
SPL
SPL Set ID 6fa4f913-de83-4175-9dad-0dedab5b69a1
Route
ORAL
Published
Effective Date 2018-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Red No. 33 Fd&c Red No. 40 Glycerin Poloxamer 407 Water Sodium Benzoate Sodium Chloride Sodium Citrate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-12

Description

Diphenhydramine HCL 12.5 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCL 12.5 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy watery eyes
  • temporarily relieves these symptoms due to the commom cold:
  • sneezing
  • runny nose
Warnings

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

  • with any other product containing didhenhydramine, even one used on skin
  • to make a child sleepy
Directions
  • if needed, take every 4-6 hours
  • do not take more than 6 doses in 24 hours
 Children under 4 years of age:  do not use
 Children 4 to under 6 years of age:  do not use unless directed by a doctor
 Children 6 to under 12 years of age:  1 to 2 teaspoonfuls (12.5 mg to 25 mg)

Drug Facts

Diphenhydramine HCL 12.5 mg

Other Information
  • keep carton for full directions for use
  • each teaspoonful contains: sodium 10 mg
  • store at 20°-25°C (68°-77°F)
  • dosage cup provided
Inactive Ingredients

Citric acid, D and C Red # 33, FD and C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944.

When Using This Product
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness
Keep Out of Reach of Children.

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If the Child Has
  • glaucoma
  • a breathing problem such as chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedatives or tranquilizers.

Discount Drug Mart Food Fair Children's Allergy Product Label

* COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY LIQUID

DISCOUNT drug mart

FOOD FAIR

CHILDREN'S ALLERGY

Diphenhydramine

Hydrochloride

Antihistamine

Relieves: Sneezing

    Runny Nose,

             Itchy Water Eyes,  

   Itchy Throat

​Alcohol-Free

Cherry Flavor

8 FL OZ (237 mL)

* This product is not manufactured or distributes by Mcneil-PPC, Inc., distributor of Benadryl® Allergy Liquid.

BX-038

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

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Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy watery eyes
  • temporarily relieves these symptoms due to the commom cold:
  • sneezing
  • runny nose
Purpose

Antihistamine

Warnings

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

  • with any other product containing didhenhydramine, even one used on skin
  • to make a child sleepy
Directions
  • if needed, take every 4-6 hours
  • do not take more than 6 doses in 24 hours
 Children under 4 years of age:  do not use
 Children 4 to under 6 years of age:  do not use unless directed by a doctor
 Children 6 to under 12 years of age:  1 to 2 teaspoonfuls (12.5 mg to 25 mg)

Drug Facts

Diphenhydramine HCL 12.5 mg

Other Information (Other information)
  • keep carton for full directions for use
  • each teaspoonful contains: sodium 10 mg
  • store at 20°-25°C (68°-77°F)
  • dosage cup provided
Inactive Ingredients (Inactive ingredients)

Citric acid, D and C Red # 33, FD and C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments? (Questions or comments?)

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944.

When Using This Product (When using this product)
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness
Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • glaucoma
  • a breathing problem such as chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking sedatives or tranquilizers.

Discount Drug Mart Food Fair Children's Allergy Product Label (DISCOUNT drug mart FOOD FAIR CHILDREN'S ALLERGY product label)

* COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY LIQUID

DISCOUNT drug mart

FOOD FAIR

CHILDREN'S ALLERGY

Diphenhydramine

Hydrochloride

Antihistamine

Relieves: Sneezing

    Runny Nose,

             Itchy Water Eyes,  

   Itchy Throat

​Alcohol-Free

Cherry Flavor

8 FL OZ (237 mL)

* This product is not manufactured or distributes by Mcneil-PPC, Inc., distributor of Benadryl® Allergy Liquid.

BX-038

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

res


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