EXTRA STRENGTH HEADACHE RELIEF- acetaminophen-aspirin-caffeine tablet, coated 
TARGET CORPORATION

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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370R NDC 11673-305- TARGET EXTRA STRENGTH HEADACHE RELIEF ASA/APAP/CAF 250/250/65MG

ACETAMINOPHEN 250 MG - ASPIRIN 250 MG (nsaid*) CAFFEINE 65 MG - * NONSTEROIDAL ANIT-INFLAMMATORY DRUG

STEARIC ACID
MINERAL OIL
SILICON DIOXIDE
HYPROMELLOSES

MICROCRYSTALLINE CELLULOSE
STARCH, CORN
POVIDONE
CARNAUBA WAX

TITANIUM DIOXIDE
SODIUM STARCH GLYCOLATE

PURPOSE

PAIN RELIEVER - PAIN RELIEVER AID

TEMPORARILY RELIEVES MINOR ACHES AND PAINS DUE TO: headache - a cold - arthritis - muscular aches - toothache - premenstrual and menstrual cramps

DO NOT USE MORE THAN DIRECTED - DRINK A FULL GLASS OF WATER WITH EACH DOSE - ADULTS AND CHILDREN 12 YEARS AND OVER: TAKE 2 CAPLETS EVERY 6 HOURS, NOT MORE THAN 8 CAPLETS IN 24 HOURS.
CHILDREN UNDER 12 YEARS: ASK A DOCTOR

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

REYE'S SYNDROME:

Children and teenagers who have or are recovering from chickenpox 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:

hives

facial swelling

asthma (sneezing)

shock

LIVER WARNING:

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

more than 8 caplets in 24 hours, which is the maximum daily amount;

with other drugs containing acetaminophen;

3 or more alcoholic drinks every day while using this product

STOMACH BLEEDING WARNING:

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

are age 60 or older;

have had stomach ulcers or bleeding problems

take a blood-thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

take more or for a longer time than directed

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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heartbeat.

100CT NDC 305

EXTRA STRENGTH HEADACHE RELIEF 
acetaminophen-aspirin-caffeine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-305
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
MINERAL OIL (UNII: T5L8T28FGP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (CAPLET) Size17mm
FlavorImprint Code TCL370
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-305-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/01/2020
Labeler - TARGET CORPORATION (006961700)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099manufacture(11673-305)

Revised: 9/2019
Document Id: 92d9fc39-f87d-92b5-e053-2995a90af65c
Set id: 8e878f9f-e692-c140-e053-2995a90a5242
Version: 2
Effective Time: 20190918
 
TARGET CORPORATION