EXCINOL EXTRA (ACETAMINOPHEN)- acetaminophen tablet, delayed release 
America Medic & Science, LLC

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.

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Excinol Extra 1000 mg

Excinol Extra 1000 mg

Drug Facts

Active Ingredient

Acetaminophen 1000 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Do not use

Ask a doctor before use if you have liver disease

Ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

These could be signs of a serious condition

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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

do not take more than directed (see overdose warning).

Adults and children 12 years and over:

Children under 12 years:

Other information

Inactive ingredients

Questions or comments?

call toll free 1-855-470-6722

Excinol Extra 1000 mg

image description

EXCINOL EXTRA (ACETAMINOPHEN) 
acetaminophen tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
Shapecapsule (CAPLET) Size8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49638-111-301 in 1 CARTON07/06/2020
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/06/2020
Labeler - America Medic & Science, LLC (071065464)
Registrant - America Medic & Science, LLC (071065464)
Establishment
NameAddressID/FEIBusiness Operations
Elvi Pharma LLC078739246manufacture(49638-111)

Revised: 9/2020
Document Id: 0721b68d-369c-4516-994e-7f8acfe3cdc2
Set id: d47a1fbc-c737-49c2-bd60-cd24e87b7986
Version: 2
Effective Time: 20200916
 
America Medic & Science, LLC