TENSION HEADACHE RELIEF- acetaminophen-caffeine tablet, coated

TENSION HEADACHE RELIEF by

Drug Labeling and Warnings

TENSION HEADACHE RELIEF by is a Otc medication manufactured, distributed, or labeled by TARGET CORPORATION, TIME CAP LABORATORIES, INC, TIME CAP LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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

PURPOSE

Pain reliever - Pain reliever aid

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TENSION HEADACHE RELIEF 
acetaminophen-caffeine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-839
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score	no score
Shape	OVAL ((Caplet))	Size	17mm
Flavor		Imprint Code	TCL373
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-839-01	100 in 1 CARTON; Type 0: Not a Combination Product	02/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/04/2020

Labeler - TARGET CORPORATION (006961700)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(11673-839)