Childrens pain relief tablet, chewable
Active ingredient (in each tablet)
Acetaminophen USP 160 mg
Pain reliever/fever reducer
- temporarily relieves minor aches and pains due to:
- the common cold
- sore throat
- temporarily reduces fever
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
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 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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use ifyour child has
Ask a doctor or pharmacist before use if your child is
taking the blood thinning drug warfarin.
When using this product
do not exceed recommended dosage.
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.
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 (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- find right dose on chart below. If possible, use weight to dose; otherwise, use age
- chew before swallowing; this product will soften in mouth for ease of chewing
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
|* or as directed by a doctor|
||under 2 years
||ask a doctor
- store at 20 to 25C (68 to 77F). Avoid high humidity.
- Tamper Evident: Do not use if carton is open or if printed seal on blister is broken or missing.
citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.
Questions or comments?
* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
2572 Brunswick Pike
Lawrenceville, NJ 08648
Ingredients and appearance - Product information
Childrens pain relief tablet, chewable- Acetaminophen
|Product Type||Human OTC Drug Label||Item Code (Source)||NDC: 58602-766|
|Route of Administration||Oral|
|Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D )||160 mgin 1|
|Anhydrous citric acid||( UNII: XF417D3PSL)|
|Silicon dioxide||( UNII: ETJ7Z6XBU4)|
|Copovidone k25-31||( UNII: D9C330MD8B)|
|Crospovidone (120 .mu.m)||( UNII: 68401960MK)|
|D&c red no. 27||( UNII: 2LRS185U6K)|
|D&c red no. 30||( UNII: 2S42T2808B)|
|Dextrose monohydrate||( UNII: LX22YL083G)|
|Ethylcellulose (4 mpa.s)||( UNII: KC5472WRJK)|
|Magnesium stearate||( UNII: 70097M6I30)|
|Mannitol||( UNII: 3OWL53L36A)|
|Sodium starch glycolate type a potato||( UNII: 5856J3G2A2)|
|Stearic acid||( UNII: 4ELV7Z65AP)|
|Sucralose||( UNII: 96K6UQ3ZD4)|
|Imprint Code||F8||Flavor||BUBBLE GUM|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|
|OTC MONOGRAPH NOT FINAL||part343||USA|
Labeler - Aurohealth LLC( 078728447)
|Aurohealth LLC||078728447||MANUFACTURE( 58602-766)|
Package label-principal display panel -160 mg(24 chewable tablets)
Children's Pain Relief
Acetaminophen 160 mg
Pain reliever/Fever reducer
- Aspirin Free
- Ibuprofen Free
Compare to the active ingredient in
Children's Tylenol® Chewables*