ACETAMINOPHEN- acetaminophen liquid 
Foxland Pharmaceuticals, Inc.

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 = 1 teaspoon (TSP))

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

To reduce fever and for the temporary relief of minor aches and pains due to:

  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The common cold
  • Toothache
  • Premenstrual and menstrual cramps

Warnings

Liver Warning

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

  • More than 5 doeses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Alcohol warning: if the user consumes 3 or more alcoholic drinks every day, ask your doctor whether the user should take acetaminophen or other pain reliever/fever reducers.

Do not use

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

Ask a doctor before use if the user has liver disease.

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

When using this product

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 5 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.

Overdose Warning

iIn case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs of symptoms.

Directions

  • do not take more than directed (see overdose warnings).
  • if needed, repeat dose every 4 hours or as directed by a doctor
  • do not give more than 5 doses in 24 hours
children under 2 yrs (under 24 lbs)ask a doctor
children 2-3 years (24-35 lbs) 1 teaspoon (TSP) (5 mL)
children 4-5 years (36-47 lbs) 1½ teaspoons (TSP) (7.5 mL)
children 6-8 years (48-59 lbs) 2 teaspoons (TSP) (10 mL)
children 9-10 years (60-71 lbs) 2½ teaspoons (TSP) (12.5 mL)
children 11 years (72-95 lbs) 3 teaspoons (TSP) (15 mL)
adults & children 12 years & older 4 teaspoons (TSP) (20 mL)

Other information

Store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

citric acid, FD&C red no. 40, cherry flavor, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, and purified water

Questions? Comments?

Call 1-205-655-3446

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

NDC 69067-100-08

See New Warnings Information
Rx Only

ACETAMINOPHEN
160 mg/5 mL

Liquid

Pain Reliever, Fever Reducer
Do not use if seal is broken or missing

237mL (8 fl oz)

Foxland
PHARMACEUTICALS, INC.

Principal Display Panel - 237 mL Bottle Label
ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69067-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CHERRY (UNII: BUC5I9595W)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69067-100-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/09/201606/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/09/201606/01/2018
Labeler - Foxland Pharmaceuticals, Inc. (079407828)

Revised: 10/2018
Document Id: 795de39b-b0f2-2329-e053-2a91aa0a2fa2
Set id: 07b58c76-580c-4b2c-934c-740ce514bb71
Version: 2
Effective Time: 20181029
 
Foxland Pharmaceuticals, Inc.