CHILDRENS NORTEMP- acetaminophen solution

Childrens Nortemp by

Drug Labeling and Warnings

Childrens Nortemp by is a Otc medication manufactured, distributed, or labeled by Ballay Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient: Acetaminophen 160mg (in each 5 mL (tsp.))

Purpose

Purpose: Pain reliever/Fever reducer

Uses

■ Temporarily reduces fever

■ Temporarily relieves minor aches and pains associated with a cold,  flu, sore throat, headache and toothache.

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.

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.

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.  In case of accidental overdose, get medical help or contact a Poison Control Center immediately . Prompt medical attention is critical even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions:  Shake well

Age (year) Weight (lb)	Under 2 Under 24	2 - 3 24 - 35	4 - 5 36 - 47	6 - 8 48 - 59	9 - 10 60 - 71	11 72 - 95
Dose (tsp.)	Consult Doctor	1	1 1/2	2	2 1/2	3

All dosages may be repeated every 4 hours, but not more than 5 times daily.  this product does not contain directions or complete warnings for adult use.

Other information
Store between 20°-25°C (68°-77°F) in a tight container.

Each teaspoon contains: Sodium 7 mg

Inactive ingredients

citric acid, FD&C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol and sucralose.

Manufactured by:

Ballay Pharmaceuticals, Inc.

200 Stillwater

Wimberley, TX 78676

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHILDRENS NORTEMP 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63162-510
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63162-510-12	118 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/26/2014

Labeler - Ballay Pharmaceuticals, Inc (035888200)