NDC | 41167-0040-2, 41167-0040-3, 41167-0040-4 |
Set ID | 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb |
Category | HUMAN OTC DRUG LABEL |
Packager | Chattem, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART338 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purposes
- Active ingredients
- Purposes
- Uses
-
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.
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- 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 medical illness.
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
- more than 4,000 mg of acetaminophen in 24 hours
-
Directions
• do not take more than directed (see overdose warning)
adults and children 12 years and older: • take 1 caplet at bedtime
• do not take more than 1 caplet 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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER
acetaminophen and diphenhydramine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0040 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM SILICATE (UNII: 9B9691B2N9) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LIGHT MINERAL OIL (UNII: N6K5787QVP) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE (White and blue) Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code UNISOM;PM;PAIN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0040-2 1 in 1 CARTON 12/01/2009 1 15 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:41167-0040-3 1 in 1 CARTON 12/01/2009 04/10/2018 2 20 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:41167-0040-4 1 in 1 CARTON 12/01/2009 3 30 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 12/01/2009 Labeler - Chattem, Inc. (003336013)