SPL v3
SPL
SPL Set ID e916ef86-ca73-42dd-83dc-6033f56d96f2
Route
ORAL
Published
Effective Date 2020-01-17
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 2014-12-02

Description

Active ingredient (in each 5 mL teaspoonful) Diphenhydramine HCL 12.5 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Active ingredient (in each 5 mL teaspoonful) Diphenhydramine HCL 12.5 mg

Uses
  • temporarily relives 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 common cold:
  • sneezing
  • runny nose
Warnings

Do not use• With any other product containing diphenhydramine, even one used on skin

  • to make a child sleepy
Directions
  • if needed, take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
 Age (yr)  Dose (mL or tsp)
 Children under 4 years  do not use
 Children 4 to under 6 years  do not use unless directed by a doctor
 Children 6 to under 12 years  1 to 2 teaspoonfuls (12.5 mg to 25 mg)

Drug Facts

Active ingredient

(in each 5 mL teaspoonful)

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

When Using This Product
  • marked drowsiness may occur
  • excitability may occur, especially in childrren
  • 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
Marcs Childrens Allergy Relief Product Label

NDC 68998-505-24

Compare to the active ingredient in children's Benadryl® allergy liquid*

Marcs

Children's

Allergy

Relief

Antihistamine

Diphenhydramine HCL

Oral Solution

Relieves:

Sneezing, Runny Nose,

Itchy Watery Eyes,

Itchy Throat

Alcohol-Free

CHERRY FLVOR

4 FL OZ (118 mL)

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

* This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of "Children's Benadryl Allergy Liquid."

Distributed By:

Marc Glassman, Inc.

West 130th Street

Cleveland, OH 44130

BX-044

Internal Label - LR-075  Lot:     Exp:

res

Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedatives or tranquilizers


Structured Label Content

Uses
  • temporarily relives 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 common cold:
  • sneezing
  • runny nose
Purpose

Antihistamine

Warnings

Do not use• With any other product containing diphenhydramine, even one used on skin

  • to make a child sleepy
Directions
  • if needed, take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
 Age (yr)  Dose (mL or tsp)
 Children under 4 years  do not use
 Children 4 to under 6 years  do not use unless directed by a doctor
 Children 6 to under 12 years  1 to 2 teaspoonfuls (12.5 mg to 25 mg)

Drug Facts

Active ingredient

(in each 5 mL teaspoonful)

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 (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

When Using This Product (When using this product)
  • marked drowsiness may occur
  • excitability may occur, especially in childrren
  • 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
Marcs Childrens Allergy Relief Product Label

NDC 68998-505-24

Compare to the active ingredient in children's Benadryl® allergy liquid*

Marcs

Children's

Allergy

Relief

Antihistamine

Diphenhydramine HCL

Oral Solution

Relieves:

Sneezing, Runny Nose,

Itchy Watery Eyes,

Itchy Throat

Alcohol-Free

CHERRY FLVOR

4 FL OZ (118 mL)

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

* This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of "Children's Benadryl Allergy Liquid."

Distributed By:

Marc Glassman, Inc.

West 130th Street

Cleveland, OH 44130

BX-044

Internal Label - LR-075  Lot:     Exp:

res

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


Advanced Ingredient Data


Raw Label Data

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