Pain Relief Rapid Release Gelcaps Extra Strength: Package Insert and Label Information

PAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH- acetaminophen tablet, coated
Safeway

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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

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 are allergic to acetaminophen or any of the inactive ingredients in this product

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.

Directions

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

adults and children 12 years and over	take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps 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

Other information

• store between 20-25ºC (68-77ºF)
• retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

COMPARE TO

Tylenol® Rapid Release Gelcaps

Active ingredient*

NDC 21130-270-01

Signature Care™

Quality Guaranteed

Extra Strength

Pain Relief

Acetaminophen 500mg

Pain Reliever.Fever Reducer

Aspirin free

Easy to swallow/rapid release

RAPID RELEASE GELCAPS

24 GELCAPS

image description

PAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH acetaminophen tablet, coated

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-270 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN STEARIC ACID TITANIUM DIOXIDE

Product Characteristics Color gray (red and light blue ends) Score no score Shape OVAL Size 19mm Flavor Imprint Code G1 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:21130-270-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 24 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (21130-270-01) 2 NDC:21130-270-13 225 TABLET, COATED in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/05/2015

Labeler — Safeway (009137209)

Revised: 10/2019 Safeway