OTC Medication Information: ASSURED REGULAR STRENGTH ACETAMINOPHEN

ASSURED REGULAR STRENGTH ACETAMINOPHEN- acetaminophen capsule, gelatin coated
SPIRIT PHARMACEUTICALS LLC

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 softgel)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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
  • do not give this product to children for the pain of arthritis unless directed by a doctor

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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

adults and children 12 years and over
  • take 2 softgels every 4 to 6 hours while symptoms last
  • do not take more than 10 softgels in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children 6-11 years
  • take 1 softgel every 4 to 6 hours while symptoms last
  • do not take more than 5 softgels in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 years ask a doctor

Other information

  • store between 20-25°C (68-77°F)

Inactive ingredients

FD&C red # 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

Call 1-888-333-9792

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL — 10 Softgel Bottle Carton

ASSURED

COMPARE TO ACTIVE INGREDIENT IN
TYLENOL® REGULAR STRENGTH*

REGULAR STRENGTH

Acetaminophen

  • Acetaminophen 325 mg
    Pain Reliever / Fever Reducer

Actual Size

10 softgels

PRINCIPAL DISPLAY PANEL -- 10 Softgel Bottle Carton
(click image for full-size original)
ASSURED REGULAR STRENGTH ACETAMINOPHEN
acetaminophen capsule, gelatin coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0012
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
GELATIN, UNSPECIFIED
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
PROPYLENE GLYCOL
WATER
SORBITOL
TITANIUM DIOXIDE
Product Characteristics
Color RED Score no score
Shape CAPSULE (OBLONG) Size 21mm
Flavor Imprint Code 800
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68210-0012-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 10 CAPSULE, GELATIN COATED in 1 BOTTLE This package is contained within the CARTON (68210-0012-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 08/12/2016
Labeler — SPIRIT PHARMACEUTICALS LLC (179621011)
Establishment
Name Address ID/FEI Operations
MEDGEL PVT LTD 872779008 MANUFACTURE (68210-0012)

Revised: 08/2016 SPIRIT PHARMACEUTICALS LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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