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- NDC Code(s): 17714-013-01, 17714-013-10
- Packager: Advance Pharmaceutical Inc.
- 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 December 22, 2017
If you are a consumer or patient please visit this version.
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- Active Ingredient
(in each tablet)
Acetaminophen 500 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 6 tablets (3,000 mg) in 24 hours. 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
do not use
- with any other drug containing acetaminophen (prescription or non prescription). 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 the 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
- redness or swelling is present
- new symptoms occur
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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 over dose warning) adults & 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 take for more than 10 days unless directed by a doctor
- children under 12 years : ask a doctor
- Other Information
- store at 15-30 °C (59-86 °F)
For Bulk package: This is a bulk package, dispense contents with a child-resistant closure in a tight, light resistant container as defined in the USP.
- Inactive Ingredients
polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid
- Questions or Comments
Call 631-981-4600 8.30 am- 4.30 pm ET, Monday-Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 17714-013-01 – 100 COUNT
NDC: 17714-013-10 – 1000 COUNT
- INGREDIENTS AND APPEARANCE
APAP
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17714-013 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 POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code AP;013 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17714-013-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/05/1989 2 NDC:17714-013-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/05/1989 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/05/1989 Labeler -Advance Pharmaceutical Inc.(078301063)
Registrant -Advance Pharmaceutical Inc. (078301063)
Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(17714-013)
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More Info on this Drug
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APAP- acetaminophen tablet
Number of versions: 2
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Dec 26, 2017 | 2 (current) | download |
| Mar 20, 2013 | 1 | download |
RxNorm
APAP- acetaminophen tablet
| 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
APAP- acetaminophen tablet
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 17714-013-01 |
| 2 | 17714-013-10 |
