Drug Labeling and Warnings

Drug Details [pdf]

DIPHENHYDRAMINE HCL STRAWBERRY FLAVOR- diphenhydramine hydrochloride solution 
IPG PHARMACEUTICALS, INC.

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Active ingredient in each 5 mL in one teaspoonful)           Purpose

Diphenhydramine HCl, 12.5 mg...................................Antihistamine

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

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on the 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 taking sedatives or tranquilizers

When using this product:

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

If pregnant or breastfeeding, 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 the 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:
 take 5 to 10 mL (1 to 2 tsp) not
to exceed 150 mg in 24 hours
Children under 6 years of age: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? 1-888-711-7116

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

Product label

image description

DIPHENHYDRAMINE HCL STRAWBERRY FLAVOR 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71085-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71085-105-19119 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/31/202604/08/2026
Labeler - IPG PHARMACEUTICALS, INC. (080441238)

Revised: 4/2026