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Acetaminophen by Physicians Total Care, Inc.

Dosage form: liquid
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-1791

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 Oral Solution USP 0182-1473-40

Drug Facts

Active ingredient (in each teaspoon (5 mL))Purpose
Acetaminophen 160 mgPain reliever - fever reducer

Uses

for the temporary relief of minor aches and pains associated with

  • a cold or flu
  • sore throat
  • headache
  • toothache
  • temporarily reduces fever

Warnings

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.

Do not use

  • with any other product containing acetaminophen
  • more than directed (see overdose warning)

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 more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions
  • find right dose on chart
  • if possible, use weight to dose; otherwise, use age
  • if needed, repeat dose every 4 hours
  • do not use more than 5 times in 24 hours
WeightAgeDose
under 24 lbsunder 2 yearsask a doctor
24 to 35 lbs2 to 3 years1 teaspoon (5 mL)
36 to 47 lbs4 to 5 years1 ½ teaspoons (7.5 mL)
48 to 59 lbs6 to 8 years2 teaspoons (10 mL)
60 to 71 lbs9 to 10 years2 ½ teaspoons (12.5 mL)
72 to 95 lbs11 years3 teaspoons (15 mL)

Other information

store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

artificial cherry flavor, benzoic acid, citric acid, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose

Questions?

Call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

PRINCIPAL DISPLAY PANEL ACETAMINOPHEN

ORAL SOLUTION USP

160 mg/5 mL

PAIN RELIEVER - FEVER REDUCER

Alcohol-Free
Aspirin-Free
Saccharin-Free
Cherry-Flavored

EACH TEASPOON (5 mL) CONTAINS:
Acetaminophen USP            160 mg

TAMPER-EVIDENT: Do not use this product if
inner foil seal over the mouth of the bottle
is cut, torn, broken or missing.

THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDREN

Distributed by:
GOLDLINE LABORATORIES, INC.
Sellersville, PA 18960
Dist. 1990 0809REV 71

Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK      74146

NDC 54868-1791-0
TAMPER-EVIDENT

ONE PINT (473 mL)

ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-1791(NDC:0182-1473)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOL 1450 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-1791-0473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34307/07/2004
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

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Medically reviewed on Dec 7, 2017

Further information

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

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