DIPHENHYDRAMINE HCL STRAWBERRY FLAVOR- diphenhydramine hcl solution

Diphenhydramine HCL STRAWBERRY FLAVOR by

Drug Labeling and Warnings

Diphenhydramine HCL STRAWBERRY FLAVOR by is a Otc medication manufactured, distributed, or labeled by Innovida Pharmaeutique Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each 5mL tsp)

Diphenhydramine HCl, 12.5 mg

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.

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

KEEP OUT OF REACH OF CHILDREN

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

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.

Questions or Comments? 1-888-462-4166

SPL UNCLASSIFIED SECTION

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

Product label

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL STRAWBERRY FLAVOR 
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71800-058
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
STRAWBERRY (UNII: 4J2TY8Y81V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71800-058-19	119 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/10/2025

Labeler - Innovida Pharmaeutique Corporation (080892908)