OTC Medication Information: EXTRA STRENGTH ACETAMINOPHEN
EXTRA STRENGTH ACETAMINOPHEN- acetaminophen tablet
Spirit Pharmaceutical LLC
Drug Facts
Active ingredient (in each caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
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
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.
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning
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 take more than directed (see overdose warning)
adults and children 12 years and over |
|
children under 12 years | ask a doctor |
Other information
- each caplet contains: magnesium 0.43 mg
- store between 20-25°C (68-77°F)
- do not use if carton is opened or inner Safety Seal is broken or missing
Inactive ingredients
Hypermellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Questions or comments?
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PRINCIPAL DISPLAY PANEL
COMPARE TO EXTRA STRENGTH TYLENOL® ACTIVE INGREDIENT*
Dr. Juan’s
Santo Remedio
PARA EL
DOLOR
Para el Dolor / Bajar La Fiebre
No Contiene Aspirina
Acetaminofén Extra Fuerte
Acetaminophen Extra Strength
Pain Reliever / Fever Reducer / Contains No Aspirin
500 MG · 100 CAPLETAS/CAPLETS
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Labeler — Spirit Pharmaceutical LLC (179621011) |
Revised: 12/2023 Spirit Pharmaceutical LLC
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.
https://otclabels.com/lib/otc/otc-meds/extra-strength-acetaminophen-3/