SPL v1
SPL
SPL Set ID 7eb709a5-c587-4f1d-bc2d-576d07a3a3bf
Route
ORAL
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Citric Acid Fd&c Red No. 40 Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sorbitol Sucralose Strawberry

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-10

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 upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.

Section 50565-1

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to the enlarged prostate gland

Ask a doctor or pharmacist before use if you are takingsedatives or tranquilizers

When using this product:

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

If pregnant of 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 (1-800-222-1222) right away.

Directions
  • Take every 4 to 6 hours, or as directed by a doctor.
  • Do not exceed recommended dose.
 Adults and Children 12 years of age and over  take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours

 Children 6 to under 12 years of age

Children under 6 years of age:

 take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours

consult a doctor

Product Label

Other Information
  • Store at controlled room temperature 15º - 30ºC (59º - 86ºF).
  • Do not refrigerate. Avoid excessive heat or humidity.
  • Protect from light.
Inactive Ingredients

Citric acid, FD&C red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, strawberry flavor, sucralose.

Active Ingredient (in Each 5ml Tsp)

Diphenhydramine HCl, 12.5 mg

Questions Or Comments? 1 888 462 4166


Structured Label Content

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.

Section 50565-1 (50565-1)

Purpose

Antihistamine

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to the enlarged prostate gland

Ask a doctor or pharmacist before use if you are takingsedatives or tranquilizers

When using this product:

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

If pregnant of 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 (1-800-222-1222) right away.

Directions
  • Take every 4 to 6 hours, or as directed by a doctor.
  • Do not exceed recommended dose.
 Adults and Children 12 years of age and over  take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours

 Children 6 to under 12 years of age

Children under 6 years of age:

 take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours

consult a doctor

Product Label (Product label)

Other Information
  • Store at controlled room temperature 15º - 30ºC (59º - 86ºF).
  • Do not refrigerate. Avoid excessive heat or humidity.
  • Protect from light.
Inactive Ingredients

Citric acid, FD&C red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, strawberry flavor, sucralose.

Active Ingredient (in Each 5ml Tsp) (Active Ingredient (in each 5mL tsp))

Diphenhydramine HCl, 12.5 mg

Questions Or Comments? 1 888 462 4166 (Questions or Comments? 1-888-462-4166)


Advanced Ingredient Data


Raw Label Data

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