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

OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution by

Drug Labeling and Warnings

OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution 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 is taking 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, 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 
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87078-411
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)

Product Characteristics
Color	white (Clear Colorless)	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87078-411-52	12 in 1 CARTON	10/06/2025
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)