EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY- acetaminophen liquid

Extra Strength Acetaminohpen by

Drug Labeling and Warnings

Extra Strength Acetaminohpen by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each 15 mL)

Acetaminophen 500 mg

Purpose

Pain reliever/Fever reducer

Uses

• temporarily relieves minor aches and pains due to
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
• temporarily reduces fever 

Warnings

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

• more than 4000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions.Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

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

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
new symptoms occur
redness or swelling is present
These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)
• do not take more than 4 doses in any 24 hour period
• measure only with dosing cup provided. Do not use any other dosing device
• mL=milliliter
• keep dosing cup with product
• adults and children 12 years and over
  • 30 mL every 6 hours while symptoms last
  • do not take more than 10 days unless directed by a doctor
• children under 12 years: do not use 

Other Information

• each 15 mL contains: sodium 6 mg
• store between 20-25ºC (68-77ºF). Do not refrigerate
• protect from light

Inactive Ingredients

citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Principal Display Panel

Major Mapap

ADULT

For ages 12 years and over

Extra Strength Actetaminophen 500 mg

Rapid Burst Cherry

Pain reliever

fever reducer

*COmpare to Extra strength Tylenol® active ingredient

Alcohol free

FL OZ (mL)

Questions or comments?
Call 1-877-753-3935

Monday-Fridat 9AM-5PM EST

Distributed by: MAjor Pharmaceuticals

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSSING.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®

Package label

Major MAPAP

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH ACETAMINOHPEN  ADULT RAPID BURST CHERRY
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5847
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Tylenol Type Cherry Rapid Blast Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5847-09	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/02/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	07/02/2009

Labeler - Major Pharmaceuticals (191427277)