DIPHENHYDRAMINE HCL capsule, liquid filled

Diphenhydramine Hcl by

Drug Labeling and Warnings

Diphenhydramine Hcl by is a Otc medication manufactured, distributed, or labeled by Agile Pharmachem. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25mg

Purpose

Sleep Aid

Uses

• For the relief of occasional sleeplessness
• Reduces time to fall asleep if have difficulty falling asleep

Warnings

Do not use

• If children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other drug that cause drowsiness such as antihistamines and nighttime cold/flu products
• Do not use with generic NyQuil®

Ask a doctor before use if you have:

• A breathing problem such as asthma, emphysema, or Chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• heart disease
• You are taking a diuretic

  Ask a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid, when using this product :

• Avoid alcoholic beverages and other drugs that cause drowsiness
• Drowsiness will occur
• Be careful when driving a motor vehicle or operating machinery

  Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks.

  Insomnia may be a symptom of serious underlying medical illness.

  If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose Warning: Taking more than directed can cause serious health problems, In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Take only one dose per day (24 hours)- see Overdose warning.

Adults and Children 12 years and over

• One Dose = Two 25 mg LiquiCaps (50 mg) at bedtime if needed or as directed by a doctor

Other Information

• Store at 20-25°C (68-77°F)
• Avoid excessive heat above 40°C(104°F) and high humidity
• Protect from light

Inactive Ingredients

FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol, Titanium Dioxide

Questions?

Call 1-855-314-1850

TAMPER EVIDENT: This Package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors. 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 58805-001-14 LIQUID GELS

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58805-001
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	602
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58805-001-14	3600 in 1 BLISTER PACK
1		1 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/15/2013

Labeler - Agile Pharmachem (650687853)

Registrant - Agile Pharmachem (650687853)