FDA Label for Little Remedies Infant Fever/pain Reliever

Active Ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Temporarily:

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

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
  
• blisters
  
• rash.

If skin reaction occurs, stop use and seek medical help right away.

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 Use:

• 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.

Stop Use And Ask A Doctor If

• 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.

Keep Out Of Reach Of Children.

Overdose 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.

Directions

• this product does not contain directions or complete warnings for adult use
  
• do not give more than directed (see overdose warning)
  
• 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 AccuSafe^®syringe
  
• remove cap, insert 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
  
• replace cap tightly to maintain child resistance

mL=mililiter

Weight (lbs)	Age (yrs)	Dose
Under 24	Under 2	Ask a doctor
24-35	2-3	5 mL

Other Information

• each 5 mL contains: sodium 6 mg
  
• store at 20-25^°C (68-77^°F)
  
• AccuSafe^® dosing device enclosed
  
• check expiration date on bottle or box before using

Inactive Ingredients

benzoic acid, carboxymethlcellulose, glycerin, natural berry flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum

Questions?

1-800-54-8853 Mon. – Fri. 8:00 a.m.to 8:00 p.m. EST

LittleRemedies.com

Principal Display Panel

Little Remedies^®
INFANT

FEVER+PAIN RELIEVER
Acetaminophen 160 mg / 5 mL

natural berry flavor
2 FL OZ (59 mL)

PRINCIPAL DISPLAY PANELLittle Remedies®INFANTFEVER+PAIN RELIEVERAcetaminophen 160 mg / 5 mLnatural berry flavor2 FL OZ (59 mL) - little remedies infant fever pain reliever berry 01