Label: NOTTS - PAIN RELIEF PM- acetaminophen, diphenhydramine hydrochloride tablet
- NDC Code(s): 82706-009-01, 82706-009-02
- Packager: VIVUNT PHARMA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 14, 2024
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- Official Label (Printer Friendly)
- 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, which is the maximum daily amount.
- 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
- rash
- blisters
If a skin reaction occurs, stop use and seek medical attention immediately.
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 are allergic to any other ingredient in this product.
Ask a doctor before use if you have
- liver disease
- breathing problems such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urinatation due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are taking
- the blood thinning drug warfarin
- sedatives or tranquilizers
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.
- pain lasts more than 10 days
- pain gets worse
- new symptoms occur
- redness or swelling is present.
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 24 Caplets
- PRINCIPAL DISPLAY PANEL - 50 Caplets
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INGREDIENTS AND APPEARANCE
NOTTS - PAIN RELIEF PM
acetaminophen, diphenhydramine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82706-009 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color blue (Light Blue) Score no score Shape OVAL Size 18mm Flavor Imprint Code NOTTS;PM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82706-009-01 1 in 1 CARTON 08/17/2022 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:82706-009-02 1 in 1 CARTON 08/17/2022 2 50 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 08/17/2022 Labeler - VIVUNT PHARMA LLC (045829437)