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Acetaminophen by Method Pharmaceuticals, LLC

Medically reviewed on May 1, 2018

Dosage form: liquid
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Method Pharmaceuticals, LLC
NDC Code: 58657-520

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.

Acetaminophen Liquid

Drug Facts

Active ingredient

(in each 5 mL teaspoonful)
Acetaminophen, USP 160 mg      

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • menstrual cramps
  • reduces fever

Warnings

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

  • more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount.
  • any other drug containing acetaminophen.
  • 3 or more alcoholic drinks every day while using this product.

Ask a doctor before use

if you have health issues especially liver disease.

Ask a doctor or pharmacist before use

if you are taking other drugs, including the blood thinner warfarin.

Do not use
  • with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Stop use and ask a doctor if
  • new symptoms occur such as rash, hives, itching or hoarseness
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

Do not exceed recommended dosage.

Overdose Warnings: 

Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.

  • adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours
  • not recommended for children under the age of 12: this adult strength product will provide more than the recommended dose (overdose), and may cause liver damage

Other Information

Store at controlled room temperature, 15°-30°C (59°-86°F). This product contains 8 mg of sodium per teaspoonful (5 mL).

Inactive Ingredients

cherry flavor, citric acid, FD and C Blue #1, FD and C Red #40, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin.

Questions?

1-877-250-3427 M-F (8 a.m. to 5 p.m. CST), or directly to Medwatch at 1-800-332-1088.

Serious side effects associated with use of this product may be reported to this number.

See New Warnings Information

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

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.

Distributed by:
Method Pharmaceutical, LLC
Arlington, TX 76006

Rev. 05/15

Lot.:

Exp.:

PRINCIPAL DISPLAY PANEL

NDC 58657-520-16
Acetaminophen Liquid
160 mg/5 Ml
Adult Liquid
Pain Reliever / Fever Reducer
Sugar Free / Alcohol Free
Aspirin Free
CHERRY FLAVOR
16 fl oz (473 mL)

ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-520
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
METHYLPARABEN 
POLYETHYLENE GLYCOLS 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58657-520-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/01/2015
Labeler - Method Pharmaceuticals, LLC (060216698)

 
Method Pharmaceuticals, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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