HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet, coated

HEADACHE RELIEF by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS - ACETAMINOPHEN/ ASPIRIN (NSAID)/ CAFFEINE (370R)

ACETAMINOPHEN/ ASPIRIN (NSAID)/ CAFFEINE (370R)

ACTIVE INGREDIENT

Active ingredient (in each caplet) Purpose
Acetaminophen 250 mg. . . . . . . . . . . . . . . . . . . . . . .Pain reliever
Aspirin 250 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever
Caffeine 65 mg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pain reliever aid

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever

Pain reliever aid

INDICATIONS & USAGE

Uses:
temporarily relieves minor aches and pains due to:

• headache
• a cold
• arthritis
• muscular aches
• toothache
• premenstrual and menstrual cramps

WARNINGS

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:

• hives
• facial swelling
• shock
• asthma (wheezing)

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 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)
• have 3 or more alcoholic drinks every day while using this product
• 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 while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

DO NOT USE

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

ASK DOCTOR

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis or kidney disease
• you are taking a diuretic

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for diabetes, gout, or arthritis
• taking any other drug or are under a doctor’s care for any serious condition

STOP USE

Stop using and ask a doctor if

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse
• you experience any of the following signs of stomach bleeding:

- feel faint

- have bloody or black stools

- vomit blood

- have stomach pain that does not get better

• ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this product.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 (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.

DOSAGE & ADMINISTRATION

Directions

• 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

OTHER INFORMATION

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

INACTIVE INGREDIENT

Inactive ingredients: carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, pregelatinized starch, povidone, sodium starch glycolate, stearic acid, titanium dioxide

QUESTIONS

Questions or Comments?

call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEADACHE RELIEF 
acetaminophen, aspirin, caffeine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0770
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE (Capsule Shaped Tablet)	Size	17mm
Flavor		Imprint Code	TCL;370
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0770-01	1 in 1 CARTON	03/31/2021
1		100 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	03/31/2021

Labeler - WALGREENS (008965063)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(0363-0770)