DIPHENHIST- diphenhydramine hydrochloride liquid

Diphenhist by

Drug Labeling and Warnings

Diphenhist by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat

Warnings

Do not use

• to make a child sleepy
• 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

• avoid alcoholic drinks
• marked drowsiness may occur
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution 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. (1-800-222-1222)

Directions

• take every 4 to 6 hours
• do not take more than 6 doses in 24 hours
• use only with enclosed dose cup. Do not use with any other device
• mL = milliliter

• Adults and children 12 years of age and over: 10 mL-20 mL (25 mg to 50 mg)
• Children 6 to 12 years of age: 5 mL- 10 mL (12.5 mg to 25 mg)
• Children 2 to 5 years of age: Do not use unless directed by a doctor
• Children under 2 years of age: Do not use

Other information

• each 5 mL contains: sodium 7 mg
• store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

artificial cherry flavor, citric acid, D&C red #33, FD&C red #40, glycerin, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution.

Questions or comments?

1-800-645-2158

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Distributed By: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Rugby ®

NDC: 0536-0770-97

ALCOHOL-FREE
ALLERGY MEDICATION

Diphenhist ®

ORAL SOLUTION
(Diphenhydramine HCl, USP)

Antihistamine

For Temporary Relief
of Symptoms of Upper Respiratory
Allergies and Hay Fever

4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

DIPHENHIST 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-0770
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)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-0770-97	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2009	09/30/2020
2	NDC: 0536-0770-85	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2009	08/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/26/2009	09/30/2020

Labeler - Rugby Laboratories Inc. (079246066)