Acetaminophen-APAP 8 Hour

Label at a glance#

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Full prescribing information#

ACTIVE INGREDIENT (IN EACH CAPLET)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP, 650 mg

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USES

INDICATIONS & USAGE SECTION

• temporarily relieves minor aches and pains due to:
  • muscular aches
  • headache
  • minor pain of arthritis
  • backache

• temporarily reduces fever

WARNINGS

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 6 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

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

Liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed (see overdose warning)

  adults and children 12 years and over	▪ take 2 caplets every 8 hours with water ▪ swallow whole - do not crush, chew, split or dissolve ▪ do not take more than 6 caplets in 24 hours ▪ do not use for more than 10 days unless directed by a doctor
  children under 12 years	▪ do not use

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

• store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
• see end panel for batch number and expiration date
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredient in Tylenol^®8 Hour^**

CAREONE^®

Use only as directed.

Lasts up to 8 HOUR

PAIN RELIEF

Acetaminophen Extended-Release Tablets, USP 650 mg

PAIN RELIEVER · FEVER REDUCER

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

For Up To 8 Hour Relief of Minor Muscle Aches & Pain

24 CAPLETS^*650 mg Each

^*Capsule-Shaped Tablets

DISTRIBUTED BY: AMERICAN SALES COMPANY

5089223/R0811

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

• Acetaminophen-APAP 8 Hour
• Acetaminophen
• CROSCARMELLOSE SODIUM
• HYPROMELLOSES
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• POVIDONE
• STARCH, PREGELATINIZED CORN
• PROPYLENE GLYCOL
• SODIUM LAURYL SULFATE
• STEARIC ACID
• TITANIUM DIOXIDE

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Ingredients#

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Product history page 1 of 2 · 43 observed states.

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