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

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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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

Tempra1DF.jpg

TEMPRA 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64613-5900
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
VANILLA (UNII: Q74T35078H)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64613-5900-130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/201105/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/10/201105/01/2017
Labeler - Bristol-Myers Squibb de Mexico, S. de R.L. de C. V. (823646211)

Revised: 5/2016
 
Bristol-Myers Squibb de Mexico, S. de R.L. de C. V.