DIPHENHIST- diphenhydramine hydrochloride liquid
Rugby Laboratories Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diphenhist ®

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

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)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

DIPHENHIST
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-0770
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/26/2009	09/30/2020

Labeler - Rugby Laboratories Inc. (079246066)

Revised: 9/2019

Document Id: 93647dad-3daf-f7c5-e053-2995a90a2974

Set id: 92fc0a85-924b-4f7b-a83c-27c56dac3014

Version: 5

Effective Time: 20190925

Rugby Laboratories Inc.