CHILDRENS PAIN AND FEVER- acetaminophen suspension
AptaPharma Inc.
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Uses temporarily ■ 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 nyour 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 a 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,
is accompanied or followed by ever, 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.
■ If your child is allergic to acetaminophen or any other of
the inactive ingredients in this product.
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 ■ 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. (1-800-222-1222) Quick medical attention is critical
for adults as well as for children even if you
do not notice any signs or symptoms.
Directions (Children's Pain & Fever)
■ this product does not contain directions or complete warnings for adult use.
■ shake well before using
■ mL = milliliter; tsp = teaspoonful
■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.
■ 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.
Weight (lb) | Age (yr) | Dose (mL or tsp)* |
under 24 | under 2 years | ask a doctor |
24-35 | 2 - 3 years | 5 mL (1 tsp) |
36-47 | 4 - 5 years | 7.5 mL (1 1/2 tsp0 |
48-59 | 6 - 8 years | 10 mL (2 tsp) |
60-71 | 9 - 10 years | 12.5. mL (2 1/2 TSP) |
72-95 | 11 years | 15 mL (3 tsp) |
*or as directed by a doctor
Attention: use only enclosed dosing cup specifically
designed for use with this product. Do not use any
other dosing device.
Directions (Infants' Pain Relief)
■ this product does not contain directions or complete warnings for adult use.
■ shake well before using
■ mL = milliliter; tsp = teaspoonful
■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.
■ 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.
Weight (lb) | Age (Yr) | Dose (mL)* |
Under 24 | Under 2 years | Ask a doctor |
24-35 | 2-3 years | 5 mL |
*or as directed by a doctor
Attention: use only enclosed dosing syringe specifially
designed for use with this product. Do not use any
other dosing device.
Other information
■ each 5 mL (1 tsp) contains; sodium 3 mg
■ store between 20-25ºC (68-77ºF)
■ do not refrigerate
■ Keep carton for full directions for use.
Inactive ingredients anhydrous citric acid,
butylparaben. D&C Red #33. FD&C Blue #1. flavor,
glycerin, high fructose corn syrup, microcrystalline
cellulose and carboxymethylcellulose sodium.
propylene glycol, purified water, sodium benzoate,
sorbitol solution, sucralose, xanthan gum.
AP SAFE® NDC 76821-526-24
COMPARE TO THE
ACTIVE INGREDIENT IN
CHILDREN'S TYLENOL®
ORAL SUSPENSION*
Children's
Pain
& Fever
Acetaminophen
Oral Suspension
Pain reliever/Fever Reducer
• Alcohol-Free
• Ibuprofen Free
• Aspirin Free
• For Ages 2 to 11
4 FL OZ (118 mL)
160 mg per 5 mL
Grape Flavor
DO NOT USE IF PRINTED NECK BAND IS
BROKEN OR MISSING
**This product is not manufactured or distributed
by McNeil Consumer Healthcare, distributor of
Children's Tylenol®Oral Suspension.
Manufactured by:
AptaPharma Inc.
1533 Union Ave.
Pennsauken. NJ 08110
AP-BX-06
Carton
Bottle
Carton
Bottle
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CHILDRENS PAIN AND FEVER
acetaminophen suspension |
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Labeler - AptaPharma Inc. (790523323) |
Registrant - AptaPharma Inc. (790523323) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
AptaPharma Inc. | 790523323 | manufacture(76281-526) |