ONESSIP DIPHENHYDRAMINE HCL 12.5 MG/ 5 ML ORAL SOLUTION (CHERRY)- diphenhydramine hcl solution

OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) by

Drug Labeling and Warnings

OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) by is a Otc medication manufactured, distributed, or labeled by MEDWISE LIFESCIENCES INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

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

WARNINGS

Warnings

DO NOT USE

Do not use

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

ASK DOCTOR

Ask a doctor before use if the child has

• a breathing problem such as chronic bronchitis
• glaucoma
• a sodium-restricted diet

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers.

WHEN USING

When using this product

• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in 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. (1-800-222-1222)

Directions

• mL = milliliter
• take every 4 to 6 hours or as directed by a doctor
• do not take more than 6 doses (6 sachets) in 24 hours
• follow the instruction given on this carton for your easy use

• Age (years): Dose (mL)
• Children under 2 Years: do not use
• Children 2 to 5 Years: do not use unless directed by doctor
• Children 6 to 11 Years: 1 Sachet (5 mL) to 2 Sachets (10 mL)

Other Information

• store between 20-25°C (68-77°F)
• Do not use if carton or sachet is torn, broken or punctured.

Inactive Ingredients

Sorbitol, sodium benzoate, sucralose, citric acid anhydrous, sodium citrate, flavor, FD&C Red No. 40, xanthan gum, glycerin, sodium saccharin, sodium EDTA, water.

Question or comments?

call 1-516-675-8915

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONESSIP DIPHENHYDRAMINE HCL 12.5 MG/ 5 ML ORAL SOLUTION (CHERRY) 
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87078-421
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
EDETATE DISODIUM (UNII: 7FLD91C86K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87078-421-52	12 in 1 CARTON	10/17/2025
1		5 mL in 1 POUCH; Type 0: Not a Combination Product

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

Labeler - MEDWISE LIFESCIENCES INC. (140161518)