DIPHENHYDRAMINE ORAL LIQUID- diphenhydramine hydrochloride liquid

Diphenhydramine Oral Liquid by

Drug Labeling and Warnings

Diphenhydramine Oral Liquid by is a Otc medication manufactured, distributed, or labeled by Rising Health, LLC, Invahealth Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient in each 5 mL ( in one teaspoonful)

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.

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.
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are 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 right away.

Directions

• take every 4-6 hours
• Do not use more than 6 dose in 24 hours

• adults and children 12 years of age and over: 2 to 4 teaspoonfuls (25 to 50 mg)
• children 6 to under 12 years of age: 1 to 2 teaspoonfuls (12.5 to 25 mg)
• children under 6 years: ask a doctor

Other information

• store at room temperature 15º - 30ºC (59º - 86ºF)
• protect from freezing
• protect from light
• each teaspoon (5 mL) contains: sodium 8 mg

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive ingredients

cherry flavor, citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

Questions or comments?

1-844-474-7464

PRINCIPAL DISPLAY PANEL

Rising Health, LLC

NDC: 57237-305-12

Diphenhydramine Hcl 12.5 mg/5 mL Oral Solution

4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE ORAL LIQUID 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-305
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
Anhydrous Citric Acid (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Sodium Benzoate (UNII: OJ245FE5EU)
Sodium Citrate (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)
Sucrose (UNII: C151H8M554)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	PINK (dark pink to pink)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-305-12	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/19/2022
2	NDC: 57237-305-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/19/2022

Labeler - Rising Health, LLC (080500961)

Establishment
Name	Address	ID/FEI	Business Operations
Invahealth Inc.		116840615	manufacture(57237-305) , pack(57237-305) , label(57237-305) , analysis(57237-305)