Other
Drug Facts
Product of China
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th Court, Suite 1901
Miami, Florida Z.C. 33156-3175
Notts - Pain Relief Pm Tablet
FDA Label NDC 82706-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Notts - Pain Relief Pm (NDC 82706-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert, do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each caplet) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain Reliever |
| Diphenhydramine HCl 25 mg | Nighttime Sleep Aid |
Uses
Temporary relief of occasional headaches, minor aches and pains with accompanying sleeplessness
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 of 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
- a sodium restricted diet
- kidney disease
- a magnesium restricted diet
When Using This Product
avoid alcoholic drinks
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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
Do not take more the recommended. In case of overdose, get medical help or contact a Poison Control Center. Prompt 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 overdose warning)
- take 2 caplets at bedtime if needed, or as directed by a doctor.
- do not take more than 2 caplets in 24 hours
| adults and children 12 years and over | |
| children under 12 years | do not use |
Other Information
- Store between 20-25°C (68-77°F)
- Each caplet contains: sodium 9 mg and magnesium 75 mg
- Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.
Inactive Ingredients
Copovidone K25, Corn Starch, Croscarmellose Sodium, FD&C Blue No. 1, Hypromellose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate Type A Corn, Silicon Dioxide, Stearic Acid, Titanium Oxide.
Principal Display Panel - 24 Caplets
NOTTS™
Pain Relief PM
Acetaminophen/ Diphenhydramine HCl
Pain Reliever
Nighttime Sleep Aid
Non-habit Forming
Compare to Tylenol® Extra Strength PM active ingredients*
NDC 82706-009-01
500 mg/ 25 mg each caplet
24 CAPLETS
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademarks Tylenol ® Extra Strength PM.
Principal Display Panel - 50 Caplets
NOTTS™
Pain Relief PM
Acetaminophen/ Diphenhydramine HCl
- Pain Reliever
- Nighttime Sleep Aid
- Non-habit Forming
Compare to Tylenol® Extra Strength PM active ingredients*
NDC 82706-009-02
500 mg/ 25 mg each caplet
50 CAPLETS
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademarks Tylenol ® Extra Strength PM.
* Please review the disclaimer below.
