ADULT EXTRA STRENGTH PAIN RELIEVER/FEVER REDUCER- acetaminophen liquid

Adult Extra Strength Pain Reliever/Fever Reducer by

Drug Labeling and Warnings

Adult Extra Strength Pain Reliever/Fever Reducer by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 15 mL)

Acetaminophen USP 500 mg

Purpose

Pain reliever/Fever reducer

Uses

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

Warnings

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

• more than 4,000 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

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 more than 10 days
• fever gets worse or lasts 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 this and all drugs out of the 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) immediately. 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)
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• mL = milliliter

• adults and children 12 years and over:
  • take 30 mL in dose cup provided every 4 to 6 hours while symptoms last
  • do not take more than 120 mL in 24 hours
  • do not take more than 10 days unless directed by a doctor
• children under 12 years:
  • do not use this adult product in children under 12 years of age this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

• each 15 mL contains: sodium 7 mg
• store at 20-25° C (68-77° F).
• dosage cup provided
• do not use if printed shrinkband is missing or broken.

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C Red 33, FD&C red 40,flavors, high fructose corn syrup, non-crystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sucralose.

Questions or comments?

1-855-274-4122
 Distributed by:
Aurohealth LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL)

NDC: 58602-515-20
PRIMARY HEALTH

COMPARE TO TYLENOL®

Extra Strength Adult Rapid
Blast Cherry active ingredient*

Extra Strength

Pain Reliever&

Fever Reducer

Adult Acetaminophen
oral Liquid 500mg/15 mL

Rapid Burst 
Cherry Flavor                         
8 FL OZ (237 mL)

 

Do not use if printed shrinkband is missing or broken.

INGREDIENTS AND APPEARANCE

ADULT EXTRA STRENGTH PAIN RELIEVER/FEVER REDUCER 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-515
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CHERRY (UNII: BUC5I9595W)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-515-20	1 in 1 CARTON	10/01/2018
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	10/01/2018

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-515)