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Name:Nortemp
Manufacturer:Ballay Pharmaceuticals, Inc
Category:Over-the-counter (OTC) Marketed Drugs


Nortemp Infants Drops

NORTEMP  - acetaminophen solution/ drops 
Ballay 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.

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Nortemp Infants Drops

Drug Facts

Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)

Purpose: Fever reducer/pain reliever

Uses

temporarily:

■ reduces fever

■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headaches ■ sore throat  ■ toothaches

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes: ■ more than 5 doses in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen

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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if your child has liver disease.

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

When using this product

  • do not exceed recommended dosage. (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 for more than 3 days. These could be signs of serious condition.

Keep out of 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 (1-800-222-1222) . Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

■ this product does not contain directions or complete warnings for adult use ■ do not give more than directed (see overdose warning) ■ find right dose chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or mixed with formula, milk, juice etc. ■if needed repeat dose every 4 hours ■do not give more than 5 times in 24 hours ■ Replace dropper tightly to maintain child resistance

Weight (lb) Age (yr) Dose (mL)
Under 24
under 2 years
Ask a Doctor
24-35
2-3 years
1.6 mL (0.8mL +0.8mL)
For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb

Other information
Store between 20°-25°C (68°-77°F)

Inactive ingredients

citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.

Comments

1-800-847-1921

Manufactured for:

BallayPharmaceuticals, Inc.
200 Stillwater St.
Wimberley , TX 78676


Carton



NORTEMP 
acetaminophen solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63162-518
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 80 mg  in 0.8 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid  
FD&C yellow no. 6  
methylparaben  
saccharin sodium  
sodium benzoate  
sodium citrate  
propylene glycol  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (wild cherry) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63162-518-30 30 mL in 1 BOTTLE, DROPPER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 04/01/1997

Labeler - Ballay Pharmaceuticals, Inc (035888200)
Registrant - Silarx Pharmaceuticals, Inc (161630033)

Revised: 06/2011 Ballay Pharmaceuticals, Inc



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


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