ALLERGY RELIEF- diphenhydramine hydrochloride tablet
International Laboratories, LLC

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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International Laboratories, Inc. Allergy Relief Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCI 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 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

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• 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 (1-800-222-1222).

Directions

• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 doses 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 20 mg
• store at 20-25ºC (68-77ºF). Avoid high humidity. Protect from light.

Inactive ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-579-1868

PRINCIPAL DISPLAY PANEL

Drug Facts Label

LB0380 Diphenhydramine 25mg Allergy Relief

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Benadryl® Allergy

Allergy Relief

DIPHENHYDRAMINE HYDROCHLORIDE,

25 mg - Antihistamine

Relief of:

Sneezing; Runny nose;

Itchy, watery eyes; Itchy throat

14 TABLETS

Actual Size

LIFT HERE TO OPEN

Allergy Relief

ALLERGY RELIEF
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54458-858(NDC:59779-418)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK (dark)	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	L479
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54458-858-14	14 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/27/2016	10/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	05/27/2016	10/31/2018

Labeler - International Laboratories, LLC (023569924)

Revised: 11/2018

Document Id: bbc23b0c-e6f0-4748-a4de-b7a7d51761da

Set id: 7a5d6015-16fc-4e7f-8b22-96671d82db70

Version: 6

Effective Time: 20181107

International Laboratories, LLC