252R - ALLERGY TIME

Set ID
eb4f7437-7fd8-4083-b50f-80b0d115bec9
Manufacturer
TIME CAP LABORATORIES, INC | TIME CAP LABORATORIES, INC.
Effective date
2019-11-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:01:39

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purpose Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings Liver warning: This product contains Acetaminophen. Severe liver damage may occur if you have: more than 8 tablets 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 Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include *skin redding *blisters *rash. If a skin reaction occurs, stop use and seek medical help right away.

OTC - DO NOT USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions And Dosage

OVERDOSAGE SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets (1,000 mg) every 6 hours while symptoms last do not take more than 6 tablets (3,000 ng) in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Other Label Information

STORAGE AND HANDLING SECTION

Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain this ingredient

NDC Codes

Ingredients

NameUNIIKind
POVIDONEFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB

Complete SPL Sections

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Acetaminophen 500 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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 SECTION

WARNINGS SECTION

Warnings Liver warning: This product contains Acetaminophen. Severe liver damage may occur if you have: more than 8 tablets 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 Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include *skin redding *blisters *rash. If a skin reaction occurs, stop use and seek medical help right away.

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - STOP USE SECTION

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

OVERDOSAGE SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets (1,000 mg) every 6 hours while symptoms last do not take more than 6 tablets (3,000 ng) in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

STORAGE AND HANDLING SECTION

STORAGE AND HANDLING SECTION

Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain this ingredient

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc97f16642-ea3a-f5da-e053-2995a90aaa08.xml2019-11-23
otc252R 100 CT LABEL.jpg2019-10-08
otc9455f5d1-5854-1b26-e053-2995a90aa310.xml2019-10-08