NASAL DECONGESTANT - pseudoephedrine hcl tablet, sugar coated
Bryant Ranch Prepack

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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DRUG FACTS

Active ingredient (in each tablet)Pseudoephedrine HCl 30 mg

PurposeNasal Decongestant

Uses

temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
temporarily restores freer breathing through the nose

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

high blood pressure
heart disease
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

When using this product

do not use more than directed

Stop use and ask a doctor if

you get nervous, dizzy or sleepless
symptoms do not improve within 7 days or accompanied by fever

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.

Directionstake every 4-6 hoursdo not take more than 4 doses in 24 hoursadults and children 12 years and over: 2 tabletschildren 6 to under 12 years: 1 tabletchildren under 6 years: do not use

Other information

store at 25°C (77°F), excursions permitted between 15°-30°C (59°-86°F)
protect from light

Inactive ingredients acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D-C red #27 aluminum lake, D-C yellow #10 aluminum lake, FD-C red #40 aluminum lake, FD-C yellow #6 aluminum lake, iron oxide black, iron oxide red, iron oxide yellow (iron oxide ochre), kaolin, microcrystalline cellulose, polyethylene glycol (PEG) - 400, pregelatinized starch, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Questions or comments? call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday

HOW SUPPLIED

Product: 63629-2625

Pseudoephedrine HCL 30 mg Tablet

NASAL DECONGESTANT
pseudoephedrine hcl tablet, sugar coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-2625(NDC:0536-4391)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
KAOLIN (UNII: 24H4NWX5CO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	TCL;016
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63629-2625-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011
2	NDC:63629-2625-2	24 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011
3	NDC:63629-2625-3	14 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/22/2011	09/24/2011

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-2625) , RELABEL(63629-2625)

Revised: 5/2018

Document Id: fc4d8c01-34aa-44d6-a615-b91e9e57e471

Set id: a5528c8e-befe-4935-aa73-e30cb4e06461

Version: 1002

Effective Time: 20180526

Bryant Ranch Prepack