ULTRA DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride solution

Ultra Diphenhydramine HCL by

Drug Labeling and Warnings

Ultra Diphenhydramine HCL by is a Otc medication manufactured, distributed, or labeled by Singular Dreamer, Ltd dba True Marker. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each 5mL tsp)

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

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 skin.
• to make a child sleepy

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if youare taking sedatives or tranquilizers.

When using this product

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

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: 10 to 20mL (2 to 4 tsp) not to exceed 300mg in 24 hours
• Children under 6 to under 12 years of age Children under six years of age:

  Take 5 to 10ml (1 to 2 tsp) not to exceed 150mg in 24 hours

  Consult a doctor

Other Information

• Store at room temperature 15° to 30°C (59° to 86°F) 
• Do not refrigerate. Avois excessive heat or humidity
• Protect from light

Inactive Ingredients

CITRIC ACID, FD&C RED NO. 40, GLYCERIN, METHYLPARABEN, PROPYLENE GLYCOL, PROPYLPARABEN, WATER, SODIUM CITRATE, SORBITOL, SUCRALOSE, Strawberry Flavor

Questions or Comments? 1-888-811-2634

Product label

INGREDIENTS AND APPEARANCE

ULTRA DIPHENHYDRAMINE HCL 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83035-1070
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: 83035-1070-9	119 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2025	05/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/14/2025	05/30/2025

Labeler - Singular Dreamer, Ltd dba True Marker (129504103)