DailyMed - 365 WHOLE FOODS MARKET ACETAMINOPHEN- acetaminophen tablet

NDC Code(s): 59368-216-01
Packager: Praxis, LLC

Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 1, 2023

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Active ingredient (in each caplet)
Acetaminophen 500 mg

Acetaminophen 500 mg
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Purpose
Pain reliever/fever reducer

Pain reliever/fever reducer
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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 ...
- 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
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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 ...
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 have ever had an allergic reaction to this product or any of its ingredients
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.

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Directions

do not take more than directed (see overdose warning) adults and children 12 years and over - take 2 caplets every 6 hours while symptoms last - do not take more than 6 caplets in 24 ...

Other information
store at 20-25°C (68-77°F)
- store at 20-25°C (68-77°F)
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Inactive ingredients
carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid - *may contain one or more of these ...

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients
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Principal Display Panel – Non Child Resistant Package (What is this?)
365 WHOLE FOODS MARKET - Extra Strength Acetaminophen 500mg - Pain Reliever/Fever Reducer - Easy to Swallow - Aspirin & Caffeine Free - Compare to the Active Ingredient in Extra Strength Tylenol® DO NOT USE ...

365 WHOLE FOODS MARKET

Extra Strength Acetaminophen 500mg

Pain Reliever/Fever Reducer

Easy to Swallow

Aspirin & Caffeine Free

Compare to the Active Ingredient in Extra Strength Tylenol®

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

ACTUAL SIZE

FOR ADULTS

100 CAPLETS

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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
Praxis, LLC		016329513	manufacture(59368-216) , label(59368-216) , pack(59368-216)

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	RxCUI	RxNorm NAME	RxTTY
1	198440	acetaminophen 500 MG Oral Tablet	PSN
2	198440	acetaminophen 500 MG Oral Tablet	SCD
3	198440	APAP 500 MG Oral Tablet	SY

Label: 365 WHOLE FOODS MARKET ACETAMINOPHEN- acetaminophen tablet

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Drug Label Info

Safety

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Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

adults and children 12 years and over	take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Label: 365 WHOLE FOODS MARKET ACETAMINOPHEN- acetaminophen tablet

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

365 WHOLE FOODS MARKET ACETAMINOPHEN- acetaminophen tablet

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365 WHOLE FOODS MARKET ACETAMINOPHEN- acetaminophen tablet

365 WHOLE FOODS MARKET ACETAMINOPHEN- acetaminophen tablet

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365 WHOLE FOODS MARKET ACETAMINOPHEN- acetaminophen tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.