Acetaminophen Aspirin Caffeine PI

ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG- acetaminophen
250mg aspirin 250mg caffeine 65mg tablet

CVS Pharmacy
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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CVS Headache Relief Geltabs
Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg
Acetaminophen 250mg
Aspirin 250mg
Caffeine 65mg
ammonium hydroxide, black iron oxide, brilliant blue FCF, corn starch, D&C yellow No.
10 lake, ethyl cellulose, FD&C blue No. 1 lake, FD&C red No. 40 lake, gelatin, glycerin,
hydroxypropyl methyl cellulose, lactose monohydrate, light liquid paraffin,
microcrystalline cellulose, povidone, pregelatinised starch, propylene glycol, shellac
glaze, sorbitol sorbitan, stearic acid, talc, titanium dioxide, triacetin.
Do not use more than directed
Drink a full glass of water with each dose
Adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8
geltabs in 24 hours
Children under 12 years: ask a doctor
Temporarily relieves minor aches and pains due to:

Headache, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual
cramps
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 geltabs in 24 hours, which is the maximum daily amount, with
other drugs contains acetaminophen, 3 or more alcoholic drinks every day while using
this product.
Stomach bleeding warning: This contains an NSAID, which mat 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 product,
take more or for a longer time than direct.
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 if you have ever had an allergic reaction to acetaminophen, aspirin, or any
other pain reliever/ fever, 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 during the last 3 months of pregnancy unless definitely 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.
OVERDOSE WARNING: Taking more than directed can cause serious health problems.
In case of overdose, get medical help or contact a Poison Control Center right away.
Pain reliever
Pain reliever
Pain reliever aid
Store at room temperature between 20-25 ºC (68-77 ºF)
Avoid excessive heat, cold, and humidity
Close cap tightly after use
Read all product information before using. Keep box for important information.
ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG
acetaminophen 250mg aspirin 250mg caffeine 65mg tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-591
Route of Administration ORAL

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 (UNII: WZ B9127XOA)
GELATIN (UNII: 2G86QN327L)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z 65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z 8S9VYZ 4B)
GLYCERIN (UNII: PDC6A3C0OX)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POVIDONE, UNSPECIFIED (UNII: FZ 989GH94E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
STARCH, CORN (UNII: O8232NY3SJ)
AMMONIA (UNII: 5138Q19F1X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
TALC (UNII: 7SEV7J4R1U)
SHELLAC (UNII: 46N107B71O)
TRIACETIN (UNII: XHX3C3X673)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
Product Characteristics
Color green (Dark Green - White) Score no s core
Shape ROUND Size 13mm
Flavor Imprint Code S77
Contains
Packaging
Marketing Start Marketing End
# Item Code Package Description
Date Date
NDC:69842-591- 200 in 1 BOTTLE; Type 0: Not a Combination
1 02/01/2021
20 Product
2 02/01/2021
80 Product
3 02/01/2021
23 Product
Marketing Information
Marketing Application Number or Monograph Marketing Start Marketing End
Category Citation Date Date
OTC monograph not
part343 02/01/2021
final
Labeler - CVS Pharmacy (062312574)
Revised: 7/2023 CVS Pharmacy

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ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG- acetaminophen

250mg aspirin 250mg caffeine 65mg tablet

Temporarily relieves minor aches and pains due to:

Route of Administration ORAL

Labeler - CVS Pharmacy (062312574)

Revised: 7/2023 CVS Pharmacy

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