EXCINOL MIGRAINE (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 Migraine (Acetaminophen)250 mg

Excinol Migraine (Acetaminophen)
250 mg

Drug Facts

Active Ingredient

Acetaminophen 250 mg
Aspirin 250 mg
Caffeine 65 mg

Purpose

Uses

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking a prescription drug for:

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. 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

Drink full glass of water with each dose

Other information

Inactive ingredients

Carnauba wax, FD&C blue # 1 al lake, hydroxypropylmethyl cellulose, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, titanium dioxide

Questions or comments?

call toll free 1-855-470-6722

Excinol Migraine (Acetaminophen)
250 mg

image description

EXCINOL MIGRAINE (ACETAMINOPHEN) 
acetaminophen tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49638-107
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color white Score no score
Shape capsule Size 8mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49638-107-30 1 in 1 CARTON 01/17/2019
1 30 in 1 BOTTLE; 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 01/17/2019
Labeler - America Medic & Science, LLC (071065464)
Registrant - America Medic & Science, LLC (071065464)
Establishment
Name Address ID/FEI Business Operations
Time Cap Laboratories, Inc. 037052099 manufacture(49638-107)

Revised: 1/2019
Document Id: 12e1c3f0-47fe-48c1-be74-37936a983597
Set id: 96c8eae2-9e3e-43ed-a3b8-86d0cac71443
Version: 1
Effective Time: 20190122
 
America Medic & Science, LLC