84f14898-dbdc-408e-a521-c88fd8290f4b

SPL v1
SPL
SPL Set ID 84f14898-dbdc-408e-a521-c88fd8290f4b
Route
oral
Published
Effective Date 2012-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (12.5 mg)
Inactive Ingredients
citric acid monohydrate d&c red no. 33 fd&c red no. 40 glycerin high fructose corn syrup poloxamer 407 water sodium benzoate sodium chloride sodium citrate sorbitol

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph final active Since 2006-06-29
Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

Medication Information

Uses
  • temporarily relieves these symptoms due to hay fever or other upper 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

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)

adults and children

12 years of age

and over

2 to 4 teaspoonfuls

(25 mg to 50 mg)
Other Information
  • each teaspoonful contains: sodium 15 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol

Description

Diphenhydramine HCl 12.5 mg

Principal Display Panel


Diphenhydramine Hydrochloride

12.5 mg/ 5 mL

NDC 54868-5622-0



Relieves:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

See New Warning and Dosing Directions

Cherry Flavored

4 fl oz (118 mL)

Alcohol Free





Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma      74146

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Questions Or Comments?

1-800-719-9260

When Using This Product
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
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.

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet
Active Ingredient (in Each 5 Ml Teaspoonful)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper 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

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)

adults and children

12 years of age

and over

2 to 4 teaspoonfuls

(25 mg to 50 mg)
Other Information (Other information)
  • each teaspoonful contains: sodium 15 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol

Principal Display Panel


Diphenhydramine Hydrochloride

12.5 mg/ 5 mL

NDC 54868-5622-0



Relieves:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

See New Warning and Dosing Directions

Cherry Flavored

4 fl oz (118 mL)

Alcohol Free





Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma      74146

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet
Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.177950 · Updated: 2026-03-14T22:53:10.919261