ACETAMINOPHEN- acetaminophen tablet 
Aurohealth LLC

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Drug Facts

Active ingredient (in each chewable tablet)


Acetaminophen USP 160 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

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

liver disease

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 dose (see overdose warning)

Stop use and ask a doctor if

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

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

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?

Call 1-855-274-4122

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




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 160 mg (24 Chewable Tablets Bottle Carton Label)

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-774
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScore2 pieces
ShapeROUNDSize16mm
FlavorImprint Code F8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-774-828 in 1 CARTON06/18/2022
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/18/2022
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777manufacture(58602-774)

Revised: 11/2023
Document Id: 0b45ff6e-f4aa-ffdd-e063-6394a90ab825
Set id: 30756257-f748-4a5d-b031-dd267d0f91ad
Version: 2
Effective Time: 20231129
 
Aurohealth LLC