DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

diphenhydramine hydrochloride by

Drug Labeling and Warnings

diphenhydramine hydrochloride by is a Otc medication manufactured, distributed, or labeled by HF Acquisition Co LLC, DBA HealthFirst. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Diphenhydramine Hydrochloride 25 mg

PURPOSE

Antihistamine

USES

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

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

Temporarily relieves these symptoms due to the common cold

runny nose
sneezing

WARNINGS

Do not use – Diphen Allergy Caplet

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

Ask a doctor before use if you have – Diphen Allergy Caplet

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

Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet

taking sedatives or tranquilizers

When using this product – Diphen Allergy Caplet

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, – Diphen Allergy Caplet

ask a health care professional before use.

Keep out of reach of children. – Diphen Allergy Caplet

In case of overdose, contact a physician or poison control center right away (1-800-222-1222).

DIRECTIONS

Do not use – Diphen Allergy Caplet
to make a child sleepy
with any other product containing diphenhydramine, even one that is used on skin.
Ask a doctor before use if you have – Diphen Allergy Caplet
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma
Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet
taking sedatives or tranquilizers
When using this product – Diphen Allergy Caplet
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, – Diphen Allergy Caplet
ask a health care professional before use.

Keep out of reach of children. – Diphen Allergy Caplet
In case of overdose, contact a physician or poison control center right away (1-800-222-1222).

OTHER SAFETY INFORMATION

protect from light
store at room temperature 68º-77ºF (20º-25ºC)
tamper-evident sealed packets
do not use any opened or torn packets

INACTIVE INGREDIENT

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN

DO NOT USE

Do not use – Diphen Allergy Caplet

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

ASK DOCTOR

Ask a doctor before use if you have – Diphen Allergy Caplet

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

Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet

taking sedatives or tranquilizers

WHEN USING

When using this product – Diphen Allergy Caplet

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, – Diphen Allergy Caplet

ask a health care professional before use.

DOSAGE & ADMINISTRATION

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

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

Temporarily relieves these symptoms due to the common cold

runny nose
sneezing

INDICATIONS & USAGE

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

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

Temporarily relieves these symptoms due to the common cold

runny nose
sneezing

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51662-1674(NDC:47682-167)
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
D&C RED NO. 27 (UNII: 2LRS185U6K)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	048;D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51662-1674-1	1 in 1 PACKET; Type 0: Not a Combination Product	01/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/01/2012

Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Establishment
Name	Address	ID/FEI	Business Operations
HF Acquisition Co LLC, DBA HealthFirst		045657305	repack(51662-1674)