Label: CHEWABLE ACETAMINOPHEN CHILDRENS- acetaminophen tablet, chewable
- NDC Code(s): 54738-092-30
- Packager: Richmond Pharmaceuticals, Inc.
- 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 October 30, 2017
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- Active ingredient (in each tablet)
Acetaminophen 80 mgClose
Pain reliever/fever reducerClose
- temporarily relieves minor aches and pains due to:
- sore throat
- the common cold
- 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
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 accidental 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
- find the 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
- do not give for more than 5 days unless directed by a doctor
Weight (lb) Age (yr) Dose (tablets)* Under 24 Under 2 Ask a doctor 24-35 2-3 2 36-47 4-5 3 48-59 6-8 4 60-71 9-10 4-5 72-95 11-12 4-6
*or as directed by a doctorClose
- Other information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- Phenylketonurics:each tablet contains: phenylalanine 5mg
- Inactive ingredients
aspartame, compressible sugar, D&C red #27(Al lake), dextorse, FD&C yellow #6(Al lake), fruit flavor, magnesium stearate, microcrystaline cellulose, prosweet, stearice acidClose
- Questions or comments?
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGClose
call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
- Principal display panel
NDC- 54738-092-30 - APAP 80MG CHEWABLE- 30 TABS
- INGREDIENTS AND APPEARANCE
CHEWABLE ACETAMINOPHEN CHILDRENS
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54738-092 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) INVERT SUGAR (UNII: ED959S6ACY) D&C RED NO. 27 (UNII: 2LRS185U6K) DEXTROSE (UNII: IY9XDZ35W2) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color pink (light) Score 2 pieces Shape ROUND Size 10mm Flavor FRUIT Imprint Code AP;051 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54738-092-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/2015 Labeler - Richmond Pharmaceuticals, Inc. (043569607) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(54738-092)