TENSION HEADACHE RELIEF- acetaminophen-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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11673-839 TARGET - TENSION HEADACHE

ACTIVE INGREDIENTS (IN EACH CAPLET)
Acetaminophen 500 mg - Caffeine 65 mg

colloidal silicon dioxide, pregelatinized starch, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol (PEG 400), povidone stearic acid,talc, titanium dioxide

Pain reliever - Pain reliever aid

USES
• temporarily relieves minor aches and pain due to: • headache - • muscular aches

DIRECTIONS


do not use more than directed

adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 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 right away (1-800-222-1221). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

WARNINGS

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


skin reddening

blisters

rash

If a skin reaction occurs, stop use and seek medical help right away.

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


more than 6 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

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 heartbeat.

100CT

TENSION HEADACHE RELIEF 
acetaminophen-caffeine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-839
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TALC (UNII: 7SEV7J4R1U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorredScoreno score
ShapeOVAL ((Caplet)) Size17mm
FlavorImprint Code TCL373
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-839-01100 in 1 CARTON; Type 0: Not a Combination Product02/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/04/2020
Labeler - TARGET CORPORATION (006961700)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099manufacture(11673-839)

Revised: 9/2019
Document Id: 92adcc61-ef65-0ca8-e053-2995a90a06b2
Set id: 8ed1679d-d3a1-11b1-e053-2995a90a61ad
Version: 4
Effective Time: 20190916
 
TARGET CORPORATION