TEMPRA  - acetaminophen liquid 
Bristol-Myers Squibb de Mexico, S. de R.L. de C. V.

Tempra for Children Acetaminophen Stage 1 0 to 36 months

Active Ingredient
(in each 1 mL)
Acetaminophen 100 mg

 
Purpose
Pain reliever/Fever reducer

Uses Temporary treatment of mild pain and fever.

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: * Pain gets worse or lasts more than 5 days * Fever gets worse or lasts more than 3 days * New symptoms occur  * Redness or swelling is present.  These could be signs of a serious condition.
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 even if you do not notice any signs or symptoms.

Keep out of reach of children.

Directions
* Find the correct dose on the chart below; if possible, use weight to dose. Otherwise use age. * Use only the enclosed dropper for use with this product.  * If needed, repeat dose every 4 hours * Do not give more than 5 times in 24 hours * Do not give more than 2 days unless directed by a doctor.  * Do not give more than directed (see overdose warning)

Weight (lb)       Age (months)          Dose Tempra
                                                    Children Drops**(mL)
Under 24 lb      Under 24 months      Ask a doctor
24 - 35 lb         24 - 36 months             1.6 mL

**Attention: Specifically designed for use with the enclosed dropper.  Use only this enclosed dropper for dosing this product.

Other Information
* Store between 20 and 25 C (68 - 77 F) avoid high humidity * See the lower side of the box for lot number and expiration date.

Inactive Ingredients
Citric Acid, D and C Red No. 33, Glycerin, Grape, Polyethylene glycol NF 1450, Propylene glycol, Purified Water, Sodium citrate, Sodium Saccharin, Vanilla and other flavors.

Tempra for Children

Acetaminophen 

Stage 1

0 to 36 months

PAIN RELIEVER AND FEVER REDUCER

Drops

100 mg/1 mL      Grape Flavor

1 Fl Oz (30mL)

See new warnings information

Do not use if cap seal is torn or broken

TEMPRA  acetaminophen  liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 64613-5900 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 100 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE   D&C RED NO. 33   GLYCERIN   POLYETHYLENE GLYCOL 1450   PROPYLENE GLYCOL   WATER   SODIUM CITRATE   SACCHARIN SODIUM   VANILLA

Product Characteristics Color      Score      Shape Size Flavor GRAPE (Grape Flavor) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64613-5900-1 30 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/10/2022

Labeler - Bristol-Myers Squibb de Mexico, S. de R.L. de C. V. (823646211)

Establishment
Name	Address	ID/FEI	Operations
Bristol-Myers Squibb de Mexico, S. de R.L. de C. V.		823646211	manufacture

Revised: 03/2011Bristol-Myers Squibb de Mexico, S. de R.L. de C. V.