EXCINOL NIGHT (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 Night (Acetaminophen)
500 mg 

Excinol Night (Acetaminophen)
500 mg

Drug Facts

Active Ingredient

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Night time sleep aid

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

Ask your doctor or pharmacist before use if you are

When using this product

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.

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

Carnauba wax, FD&C blue# 1 al lake, FD&C blue# 2 al lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin.

Questions or comments?

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Excinol Night (Acetaminophen)
500 mg

image description

EXCINOL NIGHT (ACETAMINOPHEN) 
acetaminophen tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorblueScoreno score
ShapecapsuleSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49638-105-301 in 1 CARTON01/17/2019
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/17/2019
Labeler - America Medic & Science, LLC (071065464)
Registrant - America Medic & Science, LLC (071065464)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Laboratories, Inc.037052099manufacture(49638-105)

Revised: 1/2019
Document Id: 1c30cd85-2c58-48df-bf79-c480dd1bc21b
Set id: be218645-e42b-4d37-9b63-aa2998820539
Version: 1
Effective Time: 20190122
 
America Medic & Science, LLC