Rapid Comfort Extra Strength Non Aspirin

Label at a glance#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with

• headache
• muscular aches
• minor arthritis pain
• common cold
• toothache
• menstrual cramps

For the reduction of fever.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

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

• 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

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.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

• you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

OTC - STOP USE SECTION

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse
• redness or swelling is present

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• do not use more than directed

SPL UNCLASSIFIED SECTION

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

SPL UNCLASSIFIED SECTION

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

SPL UNCLASSIFIED SECTION

• store at room temperature 59º-86ºF (15º-30ºC)
• tamper-evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.

* may contain

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

175R LSS XS Non Aspirin 500 mg Label

Rapid Comfort™

Extra Strength

Non-Aspirin

Acetaminophen 500 mg

Easy to Swallow

Film-Coated Tablets

Pull to Open

Compare active ingredient to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Products

See new warnings information

100 Tablets (50 x 2s)

Tamper-Evident Unit Dose Packets

DailyMed RxNorm Mappings#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

• Rapid Comfort Extra Strength Non Aspirin
• Acetaminophen
• CELLULOSE, MICROCRYSTALLINE
• HYPROMELLOSES
• MALTODEXTRIN
• POLYETHYLENE GLYCOL
• POVIDONE
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• STARCH, CORN
• STEARIC ACID

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 148 matching rows.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.