ALLERGY RELIEF CAPLET- diphenhydramine hydrochloride tablet, film coated

Allergy Relief Caplet by

Drug Labeling and Warnings

Allergy Relief Caplet by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 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

• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

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 to 6 hours, or as directed by a doctor
• do not take more than 6 times in 24 hours
  • adults and children 12 years and over: 1 to 2 tablets
  • children 6 to under 12 years: 1 tablet
  • children under 6 years: do not use

Other information

• each tablet contains: calcium 18.64 mg
• store between 20-25°C (68-77°F)
• avoid excessive heat, cold and humidity
• close cap tightly after use

Inactive ingredients

crosscarmellose sodium, dicalcium phosphate DT, D&C red #27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions?

call 1-888-577-8033

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 400 Tablet Bottle Label

TopCare
health®

NDC: 36800-148-40

COMPARE TO BENADRYL® ALLERGY
ULTRATAB® TABLETS ACTIVE INGREDIENT*

Allergy
Relief

DIPHENHYDRAMINE HCl 25 mg
ANTIHISTAMINE

RELIEF OF:

• Sneezing Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

400 TABLETS

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF CAPLET 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-937
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)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Talc (UNII: 7SEV7J4R1U)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	S2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-937-40	400 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/01/2021

Labeler - TOPCO ASSOCIATES LLC (006935977)