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Name:Acetaminophen
Manufacturer:Goldline Laboratories, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Acetaminophen Oral Solution USP 0182-1473-40

ACETAMINOPHEN - acetaminophen liquid 
Goldline Laboratories, 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.

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Acetaminophen Oral Solution USP 0182-1473-40

Drug Facts

Active ingredient (in each teaspoon (5 mL)) Purpose
Acetaminophen 160 mg Pain 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
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

Goldline®

NDC 0182-1473-40
TAMPER-EVIDENT

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

ONE PINT (473 mL)

Principal Display Panel

ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0182-1473
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 160 mg  in 5 mL
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 Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0182-1473-40 473 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 01/01/1990

Labeler - Goldline Laboratories, Inc. (032349292)

Revised: 12/2009 Goldline Laboratories, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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