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

Pain Reliever Fever Reducer by

Drug Labeling and Warnings

Pain Reliever Fever Reducer by is a Otc medication manufactured, distributed, or labeled by Velocity Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• Minor aches and pains
• Headaches
• Cough
• Sore throat
• Runny nose
• Sneezing
• Nasal and sinus congestion
• Temporarily reduces fever

Warnings

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

• more than 8 tablets in 24 hours which is maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

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:

• with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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

• liver disease
• Heart disease
• Thyroid disease
• Diabetes
• High blood pressure
• Glaucoma
• Cough with excessive phlegm (mucus)
• A breathing problem such as emphysema or chronic bronchitis
• Difficulty in urinating due to enlargement of prostate gland
• Persistent or chronic cough such as occurs with smoking, asthma or emphysema
• A sodium restricted diet

• ask your doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin.
• taking sedative or tranquilizers

when using this product

• do not exceed recommended dosage
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedative and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur especially in children

• Stop use and ask a doctor if

• pain, cough or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts. These could be signs of serious condition.
• Nervousness, dizziness, or sleeplessness occurs
• If pregnant or breast-feeding, ask a health professional before use

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

• do not take more than the recommended dose
• Adults and children 12 years and over: 2 tablets fully dissolved in 4 oz of water every 4 hours, Do not exceed 8 tablets in 24 hours or as directed by a doctor
• children under 12 years: do not use

Other Information

• phenylketonurics: contains phenylalanine 15 mg per tablet
• store at room temperature  , avoid excessive heat.

• 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

NDC: 76168-021-13   6 tablets

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-021
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK	Score	no score
Shape	ROUND	Size	25mm
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76168-021-13	6 in 1 BLISTER PACK
1		1 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/15/2014

Labeler - Velocity Pharma (962198409)

Registrant - Velocity Pharma (962198409)