Nasal Decongestant by Rugby Laboratories, Inc / Time Cap Labs, Inc RUGBY 29R

Nasal Decongestant by

Drug Labeling and Warnings

Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc, Time Cap Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-4391
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code TCL;016
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-4391-3524 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/201101/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/22/201101/01/2018
Labeler - Rugby Laboratories, Inc (079246066)
Registrant - Time Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Labs, Inc037052099manufacture(0536-4391)

Revised: 11/2019
 
Rugby Laboratories, Inc