Ringl Tablet (final Packaged Product)

Ringl Tablet (final Packaged Product)
SPL v7
SPL
SPL Set ID ba5a0286-3e0f-4bef-96e5-29d92f51f432
Route
ORAL
Published
Effective Date 2016-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Hydroxypropyl Cellulose, Low Substituted Cellulose, Microcrystalline Magnesium Stearate Polyvinyl Alcohol

Identifiers & Packaging

Pill Appearance
Imprint: SATO;N Shape: round Color: white Size: 10 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 1996-05-09

Description

Active ingredient (in each tablet)    Acetaminophen 325 mg


Medication Information

Warnings and Precautions

Warnings

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

    ■ adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product

    ■ child takes more than 5 doses in 24 hours

    ■ taken with other drugs containing acetaminophen

    ■ adult has 3 or more alcoholic drinks everyday while using this product



Indications and Usage

Uses

■ for the temporary relief of minor aches and pains associated with:

    ■ a cold          ■ sore throat    ■ headache    ■ toothache    ■ muscular aches

    ■ backache    ■ the premenstrual and menstrual periods (dysmenorrhea)

■ for minor pain from arthritis

■ to reduce fever

Dosage and Administration

Directions   

adults and children 12 years and over:  1 to 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses or 12 tablets in 24 hours, or as directed by a doctor    



children 11 to under 12 years of age:  1 to 1.5 tablets every 4 hours, while symptoms persist, not to exceed 5 doses or 7.5 tablets in 24 hours, or as directed by a doctor    



children 9 to under 11 years of age:  1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 5 tablets in 24 hours, or as directed by a doctor    



children 6 to under 9 years of age:  1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 5 tablets in 24 hours, or as directed by a doctor



children 4 to under 6 years of age:  3/4 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 3.75 tablets in 24 hours, or as directed by a doctor    



children 3 to under 4 years of age:  1/2 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 2.5 tablets in 24 hours, or as directed by a doctor    



children under 3 years of age:  ask a doctor   

Description

Active ingredient (in each tablet)    Acetaminophen 325 mg

Section 34081-0

Do not give to children under 3 years of age or to children for the pain of arthritis.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

■ pain persists for more than 10 days (for adults) or 5 days (for children)

■ sore throat persists for more than 2 days

■ any of the following occurs (these could be signs of a serious condition):

    ■ fever persists for more than 3 days    ■ a severe sore throat

    ■ sore throat is accompanied or followed by fever, headache, rash, nausea, or vomiting

    ■ pain or fever persists or gets worse    ■ new symptoms occur

    ■ redness or swelling is present

■ when using for pain or arthritis:

    ■ pain persists for more than 10 days    ■ redness is present

    ■ in conditions affecting children under 12 years of age

Section 50568-5

Ask a doctor or pharmacist before use if the user is

■ taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if the user has liver disease

Section 50570-1

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.

Section 51727-6

Inactive ingredients  hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, and polyvinyl alcohol.    



Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose  Pain reliever-fever reducer

Section 55106-9

Active ingredient (in each tablet)   

Acetaminophen 325 mg

Section 60561-8

Other information

■ keep tightly sealed    ■ store between 15° to 30°C (59° to 86° F)


Structured Label Content

Indications and Usage (34067-9)

Uses

■ for the temporary relief of minor aches and pains associated with:

    ■ a cold          ■ sore throat    ■ headache    ■ toothache    ■ muscular aches

    ■ backache    ■ the premenstrual and menstrual periods (dysmenorrhea)

■ for minor pain from arthritis

■ to reduce fever

Dosage and Administration (34068-7)

Directions   

adults and children 12 years and over:  1 to 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses or 12 tablets in 24 hours, or as directed by a doctor    



children 11 to under 12 years of age:  1 to 1.5 tablets every 4 hours, while symptoms persist, not to exceed 5 doses or 7.5 tablets in 24 hours, or as directed by a doctor    



children 9 to under 11 years of age:  1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 5 tablets in 24 hours, or as directed by a doctor    



children 6 to under 9 years of age:  1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 5 tablets in 24 hours, or as directed by a doctor



children 4 to under 6 years of age:  3/4 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 3.75 tablets in 24 hours, or as directed by a doctor    



children 3 to under 4 years of age:  1/2 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 2.5 tablets in 24 hours, or as directed by a doctor    



children under 3 years of age:  ask a doctor   

Warnings and Precautions (34071-1)

Warnings

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

    ■ adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product

    ■ child takes more than 5 doses in 24 hours

    ■ taken with other drugs containing acetaminophen

    ■ adult has 3 or more alcoholic drinks everyday while using this product



Section 34081-0 (34081-0)

Do not give to children under 3 years of age or to children for the pain of arthritis.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ pain persists for more than 10 days (for adults) or 5 days (for children)

■ sore throat persists for more than 2 days

■ any of the following occurs (these could be signs of a serious condition):

    ■ fever persists for more than 3 days    ■ a severe sore throat

    ■ sore throat is accompanied or followed by fever, headache, rash, nausea, or vomiting

    ■ pain or fever persists or gets worse    ■ new symptoms occur

    ■ redness or swelling is present

■ when using for pain or arthritis:

    ■ pain persists for more than 10 days    ■ redness is present

    ■ in conditions affecting children under 12 years of age

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the user is

■ taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if the user has liver disease

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients  hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, and polyvinyl alcohol.    



Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose  Pain reliever-fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)   

Acetaminophen 325 mg

Section 60561-8 (60561-8)

Other information

■ keep tightly sealed    ■ store between 15° to 30°C (59° to 86° F)


Advanced Ingredient Data


Raw Label Data

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