Label: FLAXENDOL EXTRA STRENGTH ACETAMINOPHEN- acetaminophen capsule
- NDC Code(s): 69377-002-01
- Packager: Gelpharma S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each softgel capsule)
- Uses
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Warnings
This product contains acetaminophen. Severe liver damage mayoccur if you take: Liver warning:
more than 8 softgel capsules 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
Acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert:
If a skin reaction occurs, stop use and seek medical help right away.
- skin reddening
- blisters
- rash
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.
When using this product
- do not exceed recommended dosage
- do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. If pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.
- if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
Stop using and ask a doctor if
- pain gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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INGREDIENTS AND APPEARANCE
FLAXENDOL EXTRA STRENGTH ACETAMINOPHEN
acetaminophen capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69377-002 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 FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color red Score no score Shape OVAL (27) Size 10mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69377-002-01 1 in 1 CARTON 07/01/2022 1 24 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 Drug M013 07/01/2022 Labeler - Gelpharma S.A. de C.V. (812773665)
