NASAL DECONGESTANT- pseudoephedrine hcl tablet, sugar coated
Rugby Laboratories, 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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RUGBY 29R

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal 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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

adults and children 12 years and over: 2 tablets

children 6 to under 12 years: 1 tablet

children under 6 years:

do not use

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

CARTON IMAGE

NASAL DECONGESTANT
pseudoephedrine hcl tablet, sugar coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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)
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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STARCH, CORN (UNII: O8232NY3SJ)
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:0536-4391-35	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/22/2011	01/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/22/2011	01/01/2018

Labeler - Rugby Laboratories, Inc (079246066)

Registrant - Time Cap Labs, Inc (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
Time Cap Labs, Inc		037052099	manufacture(0536-4391)

Revised: 11/2019

Document Id: 98568cca-3725-2f54-e053-2995a90a97a0

Set id: d164e450-9e52-4b64-aea0-339577403646

Version: 2

Effective Time: 20191127

Rugby Laboratories, Inc