Acetaminophen by Method Pharmaceuticals, LLC Acetaminophen Liquid

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Method Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen liquid 
Method Pharmaceuticals, LLC

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 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58657-520
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58657-520-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2018	02/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/01/2015	02/10/2020

Labeler - Method Pharmaceuticals, LLC (060216698)

Revised: 2/2020

Document Id: 9ed1fbae-2531-a739-e053-2a95a90ab0ea

34390-5

Set id: 3b7f1a38-7eed-44e8-bf1b-fbd830daedc4

Version: 5

Effective Time: 20200217

 

Method Pharmaceuticals, LLC