North Antihistamine by Honeywell Safety Products USA, Inc / Ultra Seal Corporation / UltraTab Laboratories Antihistamine

Drug Details [pdf]

NORTH ANTIHISTAMINE- diphenhydramine tablet
Honeywell Safety Products USA, Inc

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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Antihistamine

Active ingredient

(in each tablet)

Diphenhydramine HCl (25 mg)

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

Warnings

Do not use

with any other product containing diphenhydramine, even one used on the skin

Ask a doctor before use if you have

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

Ask a doctor before use

if child is taking a sedative or tranquilizer

When using this product

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and 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 usse

Keep out of the reach of children

Enter section text here

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets) not to exceed 300 mg in 24 hours

children 6 to under 12 years of age 12.5 mg** to 25 mg (1 tablet) not to exceed 150mg in 24 hours or as directed by a doctor

children under 6 years of age ask a doctor

**12.5 mg dosage strength is not available in this package
do not attempt to break tablets

Inactive ingredients

carnuba wax, colloidal silicon dioxide, croscarmellose sodium D and C red no. 27 lake, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-430-4110

image of PDP

NORTH ANTIHISTAMINE
diphenhydramine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-0097
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	pink (Pink)	Score	2 pieces
Shape	OVAL	Size	11mm
Flavor		Imprint Code	C22
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 0498-0097-20	200 in 1 BOX, UNIT-DOSE	12/02/2011
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/02/2011	11/19/2019

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Name	Address	ID/FEI	Business Operations
Establishment
Ultra Seal Corporation		085752004	pack(0498-0097)

Name	Address	ID/FEI	Business Operations
Establishment
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(0498-0097)

Revised: 11/2019

Document Id: 973c0902-c083-7be3-e053-2a95a90abba1

Set id: 8433fdab-fac2-4f29-9e0d-6c99189847a2

Version: 6

Effective Time: 20191113

Honeywell Safety Products USA, Inc