Label: ACETAMINOPHEN tablet
- NDC Code(s): 0363-9605-07
- Packager: WALGREEN CO.
- 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.
Drug Label Information
Updated September 2, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
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
- Ask a doctor before use if your child has
- Ask a doctor or pharmacist before use if your child is
- When using this product do not exceed recommended dose (see overdose warning)
- Stop use and ask a doctor if
- Keep out of reach of children.
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- find right dose on chart below. If possible, use weight to dose; otherwise, use age
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
under 2 years
ask a doctor
24 to 35 lbs
2 to 3 years
36 to 47 lbs
4 to 5 years
48 to 59 lbs
6 to 8 years
60 to 71 lbs
9 to 10 years
72 to 95 lbs
* or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 160 mg (24 Chewable Tablets Bottle Carton Label)
Compare to the active ingredient
in Children's Tylenol® Chewables††
Pain & Fever
ACETAMINOPHEN 160 mg
PAIN RELIEVER / FEVER REDUCER
Chew or crush tablets completely before swallowing
Aspirin Free Ibuprofen Free
24 CHEWABLE TABLETS ACTUAL SIZE Bubble Gum flavor
160 mg each
DO NOT USE WITH OTHER MEDICINES
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9605 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg Inactive Ingredients Ingredient Name Strength 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) Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 16mm Flavor Imprint Code F8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9605-07 4 in 1 CARTON 07/05/2021 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 07/05/2021 Labeler - WALGREEN CO. (008965063) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 MANUFACTURE(0363-9605)