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- NDC Code(s): 47682-433-33, 47682-433-99
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 7, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
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- SPL UNCLASSIFIED SECTION
Drug Facts
- ACTIVE INGREDIENT
Active ingredient (in each tablet)
Acetaminophen 500 mg
- PURPOSE
Puropse
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
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
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 DOCTOR
Ask a doctor before use if you have liver disease
- ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
- STOP USE
Stop use and ask a doctor if
■ pain gets worse or lasts more than for 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.
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
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 use more than directed (see overdose warning)
Adults and children 12 years and over ■ take 2 tablets every 6 hours while symptoms last. ■ do not take more than 6 tablets 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 SAFETY INFORMATION
Other information
■ store at room temperature 59º-86ºF (15º-30ºC)
■ TAMPER EVIDENT child resistant packets
■ do not use any opened or torn packets
- INACTIVE INGREDIENT
Inactive ingredients
corn starch, hypromellose*, polyethylene glycol*, povidone, pregelatinized starch*, sodium starch glycolate*, stearic acid*, titanium dioxide*
* May contain
- QUESTIONS
Questions or comments? 1-800-634-7680
- PRINCIPAL DISPLAY PANEL
Medique® @ Home
APAP Extra Strength Tablets
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Pull to Open
Child-Resistant Packets
*not the actual size
50 Packets
(2 Tablets Per Packet)
Compare to the active ingredient in Extra Strength Tylenol® Tablets
- INGREDIENTS AND APPEARANCE
MEDIQUE AT HOME APAP EXTRA STRENGTH
acetaminophen 500 mg tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-433 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POVIDONE (UNII: FZ989GH94E) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code AZ;235 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-433-33 50 in 1 BOX 02/01/2021 1 NDC:47682-433-99 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-433-99 2 in 1 PACKET; Type 0: Not a Combination Product 02/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/01/2021 Labeler -Unifirst First Aid Corporation(832947092)
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More Info on this Drug
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MEDIQUE AT HOME APAP EXTRA STRENGTH- acetaminophen 500 mg tablet, film coated
Number of versions: 8
Published Date (What is this?) | Version | Files |
---|---|---|
Feb 10, 2025 | 8 (current) | download |
Jan 29, 2025 | 7 | download |
Nov 11, 2024 | 6 | download |
Jun 9, 2023 | 5 | download |
Feb 24, 2023 | 4 | download |
Mar 18, 2022 | 3 | download |
Jul 9, 2021 | 2 | download |
Feb 1, 2021 | 1 | download |
RxNorm
MEDIQUE AT HOME APAP EXTRA STRENGTH- acetaminophen 500 mg tablet, film coated
RxCUI | RxNorm NAME | RxTTY | |
---|---|---|---|
1 | 198440 | acetaminophen 500 MG Oral Tablet | PSN |
2 | 198440 | acetaminophen 500 MG Oral Tablet | SCD |
3 | 198440 | APAP 500 MG Oral Tablet | SY |
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NDC Codes
MEDIQUE AT HOME APAP EXTRA STRENGTH- acetaminophen 500 mg tablet, film coated
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 47682-433-33 |
2 | 47682-433-99 |