Little Fevers Infant Grape Fever/Pain Reliever description, usages, side effects, indications, overdosage, supplying and lots more!

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Little Fevers Infant Grape Fever/Pain Reliever

Medtech Products Inc.

Little Fevers Infant Grape Fever Pain Reliever




FULL PRESCRIBING INFORMATION

Drug Facts

(in each 5.0 mL )

Acetaminophen 160mg

Pain Reliever/Fever Reducer

Temporarily:

  • reduces fever
  • relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.

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.

if your child has liver disease.

if your child is taking the blood thinning drug warfarin .

  • with any other products containing acetaminophen (prescription or non-prescription). 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.

Sore Throat Warning: If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

DO NOT EXCEED RECOMMENDED DOSAGE; taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage.

  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 5 days
  • redness or swelling is present. These could be signs of a serious condition.

Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms.

This product does not contain directions or complete warnings for adult use.

  • Shake well before using.
  • Find the right dose on the chart below. (If possible, use weight to determine dose; otherwise, use age.)
  • Only use the enclosed AccuSafeTM syringe.
  • Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • Remove cap, attach syringe to flow restrictor and invert bottle.
  • Pull back syringe until filled to prescribed level and slowly dispense the liquid into your child’s mouth (toward the inner cheek).
  • If needed, repeat dose every 4 hours while symptoms last.
  • Do not give more than 5 times in any 24-hour period (see overdose warning).
  • Replace cap tightly to maintain child resistance.
Weight (lbs) Age (yrs) Dose
Under 24 Under 2 Ask a doctor
24-35 2-3 5.0 mL
36-47 4-5 7.5 mL
  • Store at 20-25ºC (68-77ºF)
  • AccuSafeTM dosing device enclosed.
  • Tamper Evident: Do not use if printed shrinkband on bottle is broken or missing. Check expiration date on bottle or box before using.

Citric Acid, Glycerin, High Fructose Corn Syrup, Natural Flavors, Polyethylene Glycol, Propylene Glycol, Purified Water, Sodium Benzoate and Sucralose

For further information you may contact us at: 1-800-7-LITTLE Mon. – Fri. 8:00 a.m.to 8:00 p.m. EST, or visit us at www.LittleRemedies.com.

MEDICATED FOR INFANTS
Little Fevers® by Little Remedies®
NEW! AccuSafeTM System
INFANT FEVER/PAIN RELIEVER
Acetaminophen
DYE-FREE
NO ARTIFICIAL FLAVORS
NO ALCOHOL, SACCHARIN OR DYES
GLUTEN FREE!
Natural GRAPE Flavor
SEE NEW DOSING INFORMATION.
2 FL. OZ. (59 mL)

Little Fevers Infant Grape Fever/Pain Reliever

Little Fevers Infant Grape Fever/Pain Reliever

Acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63029-611
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
Citric acid
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
polyethylene glycol
propylene glycol
water
SODIUM BENZOATE
Sucralose

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 59 in 1 BOTTLE
2 1 in 1 BOX
3 NDC:63029-611-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-07-01


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Be sure to consult your doctor before taking any medication!
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