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Acetaminophen

Physicians Total Care, Inc.

Acetaminophen Oral Solution USP 0182-1473-40


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

Acetaminophen 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
Weight Age Dose
under 24 lbs under 2 years ask a doctor
24 to 35 lbs 2 to 3 years 1 teaspoon (5 mL)
36 to 47 lbs 4 to 5 years 1 ½ teaspoons (7.5 mL)
48 to 59 lbs 6 to 8 years 2 teaspoons (10 mL)
60 to 71 lbs 9 to 10 years 2 ½ teaspoons (12.5 mL)
72 to 95 lbs 11 years 3 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

Acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-1791(NDC:0182-1473)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
red

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-1791-0 473 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2004-07-07


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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