RUGBY DIPHENHIST- diphenhydramine hcl tablet, film coated

Rugby Diphenhist by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each captab)

Diphenhydramine HCl 25 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

WARNINGS

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
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis
  

Ask a doctor or pharmacist if you are taking sedatives or tranquilizers.

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• 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)

DOSAGE & ADMINISTRATION

Directions

• take every 4 to 6 hours as needed
• do not take more than 12 captabs in 24 hours or as directed by a doctor
• Adults and children 12 years and older 1 to 2 captabs (25 mg to 50 mg)
• Children under 12 years consult a doctor
  

STORAGE AND HANDLING

Other information

• Each captab contains: Calcium 15 mg
• store at room temperature in a dry place
• keep lid tightly closed
  

INACTIVE INGREDIENT

Inactive ingredients

Croscarmellose sodium, D&C red #27, dicalcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silica, stearic acid and titanium dioxide.

QUESTIONS

Questions or comments?

call 1-800-645-2158

OTHER SAFETY INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

PRINCIPAL DISPLAY PANEL

Rugby®

NDC: 0536-1016-01

Diphenhist®

Diphenhydramine HCl 25 mg EACH

Antihistamine

100 CAPTABS

INGREDIENTS AND APPEARANCE

RUGBY DIPHENHIST 
diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (Film Coated)	Score	no score
Shape	CAPSULE (Biconvex Caplet)	Size	3mm
Flavor		Imprint Code	G17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1016-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/13/2014	08/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/13/2014	08/31/2021

Labeler - RUGBY LABORATORIES (079246066)