Label: ACETAMINOPHEN tablet
- NDC Code(s): 58602-774-82
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 29, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
-
Warnings
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
- 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 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.
-
Directions
- 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
Weight (lb)
Age (yr)
Dose (tablets)*
under 24
under 2 years
ask a doctor
24 to 35 lbs
2 to 3 years
1 tablet
36 to 47 lbs
4 to 5 years
1½ tablets
48 to 59 lbs
6 to 8 years
2 tablets
60 to 71 lbs
9 to 10 years
2½ tablets
72 to 95 lbs
11 years
3 tablets
* or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 160 mg (48 Chewable Tablets Blister Carton Label)
Healthy Living TM
Ages 2-11 DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
CHILDREN’S PAIN RELIEF
acetaminophen chewable tablets 160 mg
Pain Reliever / Fever Reducer
160 mg
per Tablet
Pain + Fever
Chewables - Chew or crush
tablets completely before swallowing
Compare
to the active
ingredient in
Children's
Tylenol ®
Chewables
• Aspirin Free
• Ibuprofen Free
Bubble Gum Flavor Actual Size
48 Chewable Tablets
160 mg each
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-774 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:58602-774-82 8 in 1 CARTON 06/18/2022 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 Drug M013 06/18/2022 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 manufacture(58602-774)