NDC | 68998-171-03 |
Set ID | 10f6c8ff-c71d-4281-8ab8-741daff1d646 |
Category | HUMAN OTC DRUG LABEL |
Packager | Marc Glassman, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
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.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- 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
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Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over - take 2 gelcaps at bedtime
- do not take more than 2 gelcaps of this product in 24 hours
children under 12 years - do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Other information
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Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, edible ink, FD&C blue #1, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEVER PM EXTRA STRENGTH
acetaminophen and diphenhydramine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68998-171 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) 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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color gray (dark blue and light blue ends) Score no score Shape OVAL Size 19mm Flavor Imprint Code G3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68998-171-03 1 in 1 CARTON 05/01/2014 1 80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2014 Labeler - Marc Glassman, Inc. (094487477)