Label: CHILDRENS CHEWABLE MAPAP- acetaminophen tablet, chewable
- NDC Code(s): 50090-0427-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0904-5256
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 22, 2017
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredient (in each chewable tablet)
Acetaminophen 80 mgClose
Pain Reliever/Fever ReducerClose
- INDICATIONS & USAGE
- temporarily relieves minor aches and pain 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.Close
- DO NOT USE
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 DOCTOR
Ask a doctor before use if your child has liver disease.Close
- ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarinClose
- WHEN USING
When using this product, do not exceed recommended dose (see overdose warning)Close
- STOP USE
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.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
Overdose warning: In the 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.Close
- DOSAGE & ADMINISTRATION
- this products does not contain directions or complete warnings for adult use.
- find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
- chew before swallowing
- 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 Age Dosage Under 24 lbs Under 2 years Ask a doctor 24-35 lbs 2-3 years 2 tablets 36-47 lbs 4-5 years 3 tablets 48-59 lbs 6-8 years 4 tablets 60-71 lbs 9-10 years 5 tablets 72-95 lbs 11 years 6 tablets
- SPL UNCLASSIFIED SECTION
- Phenylketonurics: Contain Phenylalanine 14 mg per tablet
- Store at room temperature in a dry place
- INACTIVE INGREDIENT
Inactive ingredients Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.Close
Questions or comments?
Call: (800) 616-2471Close
- SPL UNCLASSIFIED SECTION
17177 N LAUREL PARK DRIVE, SUITE 233
LIVONIA, MI 48152
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGClose
- HOW SUPPLIED
NDC: 50090-0427-0 30 TABLET, CHEWABLE in a BOTTLEClose
- INGREDIENTS AND APPEARANCE
CHILDRENS CHEWABLE MAPAP
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-0427(NDC:0904-5256) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) D&C RED NO. 27 (UNII: 2LRS185U6K) Product Characteristics Color pink Score no score Shape ROUND (ROUND BICONVEX TABLET) Size 10mm Flavor Imprint Code 1G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-0427-0 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/28/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/04/2011 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-0427)