DIPHENHYDRAMINE ORAL SOLUTION- diphenhydramine kci12.5mg/5ml solution

Diphenhydramine Oral Solution by

Drug Labeling and Warnings

Diphenhydramine Oral Solution by is a Otc medication manufactured, distributed, or labeled by Aldama Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL-teaspoonful)

Diphenhydramine KCI 12.5mg

Purpose

Antihistamine

Uses

• Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes

Temporarily relieves these symptoms due to the common cold

• runny nose
• sneezing

Warnings

Do not use

with any other drug containing diphenhydramine, including one used on the skin.
to make a child sleepy

Do not use

• with any other drug containing diphenhydramine, including one used on the skin.
• to make a child sleepy

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

• excitability may occur, especially in children
• marked drowsiness may occur
• be careful when driving motor vehicle or operating machinery
• avoid alcoholic drinks

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 right away.

Directions

• Take every 4 hours, as needed, or as directed by a doctor
• Do not take more than 6 doses in 24 hours
• adults and children 12 years and over: 10 to 20 ml 2 to 4 teaspoonsful
• Children under 12 years: consult a doctor

Other information

• TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing
• store at room temperature between 15-30°C (59-86°F)
• do not freeze
• protect from light
• Pharmacist: For dispensing, use a light-resistent container with a child-resistant cap

Inactive Ingredient

artificial and natural cherry flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Question or Comments?

305-592-9216 or info@aldamapharm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE ORAL SOLUTION 
diphenhydramine kci12.5mg/5ml solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73564-814
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
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73564-814-16	1 in 1 BOX	01/01/2026
1		473 mL in 1 BOTTLE; 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	01/01/2026

Labeler - Aldama Pharmaceuticals, Inc (119484030)

Establishment
Name	Address	ID/FEI	Business Operations
Aldama Pharmaceuticals, Inc		119484030	manufacture(73564-814)