PAIN RELIEVER FEVER REDUCER - acetaminophen,dextromethorphan hydrobromide,phenylephrine hydrochloride,chlorpheniramine maleate tablet, effervescent 
Velocity Pharma

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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Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBrand Phenylephrine HCl

Active Ingredient

(in each tablet)

Acetaminophen 250 mg

Chlorpheniramine Maleate 2mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

pain reliever/fever reducer

Antihistamine

Cough Suppressant

Nasal decongestant

Uses

Temporarily relieves these symptoms due to cold or flu:

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

Sore throat waring: If sore throat is sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly. Do not use to sedate children.

do not use:

Ask a doctor before use if you have

ask your doctor or pharmacist before use if you are

when using this product

Stop use and ask a doctor if

Keep out of reach of children.

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Direction

Other Information

Total sodium : 415 mg/tablet

Total potassium: 1mg /tablet

INACTIVE INGREDIENT

acesulfame potassium, aspartame, citric acid anhydrous, color ponceau 4r, isopropyl alcohol, mannitol, orange flavor, pvp k-30, Simethicone, sodium benzoate, sodium bicarbonate, sodium saccharin, tween 80.

QUESTIONS

Call toll free 1-855-314-1850

Distributed by Velocity Pharma Llc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

240453b0-figure-01

NDC: 76168-021-13   6 tablets

PAIN RELIEVER FEVER REDUCER 
acetaminophen,dextromethorphan hydrobromide,phenylephrine hydrochloride,chlorpheniramine maleate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PONCEAU 4R (UNII: Z525CBK9PG)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MANNITOL (UNII: 3OWL53L36A)  
ORANGE (UNII: 5EVU04N5QU)  
POVIDONE K30 (UNII: U725QWY32X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize25mm
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-021-136 in 1 BLISTER PACK
11 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/2014
Labeler - Velocity Pharma (962198409)
Registrant - Velocity Pharma (962198409)

Revised: 8/2014
Document Id: 240453b0-189a-401e-9f2e-2bf977f7aaa6
Set id: 8600db56-a877-4557-ab71-d46b72d642c9
Version: 1
Effective Time: 20140824
 
Velocity Pharma