HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet

Headache Relief by

Drug Labeling and Warnings

Headache Relief by is a Otc medication manufactured, distributed, or labeled by Walmart Inc., TIME CAP LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

PURPOSE

Purposes
Pain reliever
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

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: 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.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:
hives
facial swelling
asthma (wheezing)
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)
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
if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

ASK DOCTOR

Ask a doctor before use if
you have liver disease
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
you have asthma

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 use and ask a doctor if
an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:
-feel faint
-vomit blood
-have bloody or black stools
-have stomach pain that does not get better
ringing in the ears or loss of hearing occurs
painful area is red or swollen
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
any new symptoms occur
These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information
store at 20°- 25°C (68°- 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, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxid

QUESTIONS

Questions or comments? Call 1-888-287-1915

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEADACHE RELIEF 
acetaminophen, aspirin, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-370
Route of Administration	ORAL

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

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

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE (Caplet)	Size	18mm
Flavor		Imprint Code	TCL370
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79903-370-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2024
2	NDC: 79903-370-21	2 in 1 CARTON	07/30/2024
2	NDC: 79903-370-01	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 Drug	M013	07/30/2024

Labeler - Walmart Inc. (051957769)

Registrant - TIME CAP LABORATORIES INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES INC		037052099	manufacture(79903-370)