Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen capsule
- NDC Code(s): 55319-541-50
- Packager: Family Dollar (FAMILY WELLNESS)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated October 20, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each gelcap)
- Purpose
- Uses
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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
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
Keep out of reach of children.
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.
- Direction
- other information
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Inactive ingredients
ammonium hydroxide, croscarmellose sodium, D&C red #33, 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, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, purified water, shellac, silicon dioxide, stearic acid, titanium dioxide
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Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL® EXTRA STRENGTH RAPID RELEASE GELS†
EXTRA STRENGTH
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Adult
For Ages 12 Years and Over
RAPID RELEASE GELCAPS
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.Rapid Release Gels.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE RD, MATTHEWS, NC 28105
- Product Label
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN EXTRA STRENGTH
acetaminophen capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-541 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISOPROPYL ALCOHOL (UNII: ND2M416302) SHELLAC (UNII: 46N107B71O) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) AMMONIA (UNII: 5138Q19F1X) Product Characteristics Color red, gray, blue Score no score Shape CAPSULE Size 20mm Flavor Imprint Code G1G1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-541-50 1 in 1 BOX 07/31/2018 04/26/2024 1 50 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/31/2018 04/26/2024 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
