Cough relief capsule, liquid filled

Spl unclassified section

Drug Facts

Active ingredient (in each softgel)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough Suppressant

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

Otc - do not use section

Do not use ifyou 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 the user has

  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Otc - stop use section

Stop use and ask a doctor ifcough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Otc - pregnancy or breast feeding section

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.

Directions

  • do not take more than 8 softgels in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

take 2 softgels every 6 to 8 hours, as needed

children under 12 years

do not use

Other information

  • store at room temperature 15-30C (59-86F)
  • avoid excessive heat above 40C (104F)
  • protect from light

Inactive ingredients

FD&C blue #1, FD&C red #40,gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water,sorbitol specialand white edible ink

Questions or comments?

1-855-215-8180

Ingredients and appearance - Product information

Cough relief capsule, liquid filled- Dextromethorphan hydrobromide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 51013-125
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 15 mgin 1

Inactive Ingredients

Ingredient Name Code
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Gelatin ( UNII: 2G86QN327L)
Glycerin ( UNII: PDC6A3C0OX)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Povidone ( UNII: FZ989GH94E)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sorbitol ( UNII: 506T60A25R)

Product Characteristics

Color red (clear) Shape capsule (oval)
Size 14 mm Score 1
Imprint Code PC6

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - PuraCap Pharmaceutical LLC( 962106329)

Establishment

Name ID/FEI Business Operations
PuraCap Pharmaceutical LLC 962106329 manufacture( 51013-125), analysis( 51013-125)

Principal display panel

DISCOUNT drug mart

Adult Long-lasting Cough Relief

Dextromethorphan HBr, USP 15 mg 20 Softgels

NDC 51013-125-15