INFANTS ACETAMINOPHEN CONCENTRATED- acetaminophen suspension/ drops
Western Family Foods Inc
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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Active ingredient (in each 0.8 mL)
Acetaminophen 80 mg
Purpose
Fever reducer/pain reliever
Uses
temporarily:
- •
- reduces fever
- •
- relieves minor aches and pains due to:
- •
- the common cold
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- 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
- •
- 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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
- •
- do not give more than directed (see Liver warning)
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- shake well before using
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- find right dose on chart. If possible, use weight to dose; otherwise use age.
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- use only enclosed dropper designed for use with this product. Do not use any other dosing device.
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- fill to dose level
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- dispense liquid slowly into child’s mouth, toward inner cheek
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- if needed, repeat dose every 4 hours while symptoms last
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- do not give more than 5 times in 24 hours
- •
- do not give for more than 5 days unless directed by a doctor
- •
- replace dropper tightly to maintain child resistance
- •
- this product does not contain directions or complete warnings for adult use
Dosing Chart
|
Weight(lb)
|
Age(yr)
|
Dose (mL)
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under 24
|
under 2 years
|
ask a doctor
|
24-35
|
2–3 years
|
1.6 mL (0.8 + 0.8 mL)
|
Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device.
Other information
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- store at 20°-25°C (68°-77°F)
- •
- do not use if printed bottle wrap is broken or missing
Inactive ingredients
anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution
Principal Display Panel
See New Warnings Information
Pain Reliever - Fever Reducer
Infants’
Acetaminophen
Concentrated Drops
Aspirin Free
Ibuprofen Free
Alcohol Free
Use only with enclosed dropper
Grape Flavor
Compare to Concentrated Tylenol® Infants’ Drops active ingredient
80 mg per 0.8 mL