INFANTS PAIN AND FEVER- acetaminophen solution

Infants Pain and Fever by

Drug Labeling and Warnings

Infants Pain and Fever by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each 5 mL)

Acetaminophen, 160 mg

Purpose

Pain reliever/ fever reducer

Uses

 reduces fever

 relieves minor aches and pains due to:

the common cold  flu  headache  sore throat  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 for this product.
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.
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

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.
 for more than 10 days for pain unless directed by a doctor.
 for more than 3 days for fever unless directed by a doctor.

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.

Keep out of reach of children.

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. (1-800-222-1222)

Directions

do not give more than directed (see overdose warning).  use the chart below to confirm dose. If possible, use weight to confirm, otherwise use age. ■ give the recommended number of vials below following the instructions under How to Open and Use on the side panel.  empty each Single-Use Vial required of all liquid when dosing.  if needed, repeat dose every 4 hours while symptoms last.  do not give more than 5 times in 24 hours.  do not give for more than 5 days unless directed by a doctor. this product does not contain directions or complete warnings for adult use.

Dosing Chart 

Weight	Age	Dose (mL)
under 24 lbs	under 2 years	Talk to a doctor
24-35 lbs	2-3 years	1 Single-Use Vial (5 mL) Every 4 hours while symptoms last. Do not exceed 5 Single-use Vials in 24 hrs

Other Information

• each Single-Use Vial contains 8mg of sodium.
• store at 20-25 °C (68-77 °F).
• tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken.

Inactive Ingredients

Citric Acid, Cherry Flavor, Edetate Disodium, Glycerin, Maltitol, Polyethylene Glycol, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Metabisulfite, Sorbitol, Sucralose, Trisodium Citrate Dihydrate, Xanthan Gum.

Questions or Comments?

1-800-719-9260

Package Labeling:

INGREDIENTS AND APPEARANCE

INFANTS PAIN AND FEVER 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-258
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-258-01	1 in 1 BOX	12/28/2018
1		100 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/28/2018

Labeler - CVS Pharmacy (062312574)