BASIC CARE HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet, film coated 
Amazon.com Services LLC

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.

----------

Amazon Headache Relief Drug Facts

Active ingredients (in each geltab)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:
headache
a cold
arthritis
muscular aches
toothache
premenstrual & 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 4,000 mg of acetaminophen in 24 hours
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 heart beat.

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 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 a doctor or pharmacist before use if you are

taking

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

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

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.

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

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 geltabs every 6 hours; not more than 8 geltabs in 24 hours
children under 12 years: ask a doctor

Other information

store at 20° -25°C (68° -77°F)
close cap tightly after use
read all product information before using. Keep this box for important information.

Inactive ingredients

black iron oxide, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polyvinyl acetate phthalate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

amazon

basic care

Extra Strength

Compare to Excedrin® Extra Strength active ingredients

Headache Relief

Acetaminophen/Aspirin (NSAID)/Caffeine

Pain Reliever/Pain Reliever Aid

See New Warning

80 GELTABS

actual size

2h0-bn-headache-relief
BASIC CARE HEADACHE RELIEF 
acetaminophen, aspirin, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-252
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTITOL (UNII: D65DG142WK)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
Product Characteristics
ColorGREEN, WHITEScoreno score
ShapeROUNDSize13mm
FlavorImprint Code M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72288-252-271 in 1 CARTON10/06/2021
180 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/06/2021
Labeler - Amazon.com Services LLC (128990418)

Revised: 5/2022
Document Id: c8c38311-be7d-48ed-8e18-a804ebc4f90c
Set id: f85d2f4c-8184-4555-a310-3979722e860b
Version: 3
Effective Time: 20220512
 
Amazon.com Services LLC