PHARBEDRYL- diphenhydramine hcl 50mg capsule

PHARBEDRYL by

Drug Labeling and Warnings

PHARBEDRYL by is a Otc medication manufactured, distributed, or labeled by Ulai Health LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each banded capsule)

Diphenhydramine HCl 50mg

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 common cold:
• runny nose
• sneezing

Warnings

Do not use

• 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

• drowsiness may occur
• avoid alcoholic drinks

• alcohol, sedatives & tranquilizers may increase drowsiness

• 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).

Directions

• take every 4 to 6 hours, or as directed by a doctor
• do not exceed 6 doses in 24 hours

• adults and children 12 years and over:

  1 capsule

• children under 12 years:

  ask a doctor

Other information

• store at 20-25oC (68-77oF)

Inactive ingredients

black iron oxide, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

Questions or comments?

(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

PRINCIPAL DISPLAY PANEL

PHARBEST

NDC: 73057-347-11

Manufactured in the USA

PHARBEDRYL

Diphenhydramine HCl 50 mg

Antihistamine

Sneezing                   Runny Nose

Itchy, Watery Eyes     Itchy Throat

1000 CAPSULES

INGREDIENTS AND APPEARANCE

PHARBEDRYL 
diphenhydramine hcl 50mg capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73057-347
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	pink (Pink/ Pink)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	PH013
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73057-347-11	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/02/2019
2	NDC: 73057-347-08	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/02/2019

Labeler - Ulai Health LLC (081181535)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(73057-347) , analysis(73057-347) , pack(73057-347) , label(73057-347)