Indications and uses
• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
• take with a full glass of water • Do not take more than directed. SEE OVERDOSE WARNING. • do not take more than 2 caplets in 24 hours adults and children 12 years of age and over • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours children under 12 years of age • do not use
• Store at room temperature between 20-25°C (68-77°F). • avoid excessive heat, cold and humidity. • close cap tightly after use.
Acetaminophen 500mg
Diphenhydramine HCl 25mg
Pain reliever
Nighttime sleep aid
• temporary relief of occasional headaches and 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
• 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
• blisters
• rash
If a skin reaction occurs, stop use and seek medical help right away.
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 last 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 WARNINGS: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
• take with a full glass of water
• Do not take more than directed. SEE OVERDOSE WARNING.
• do not take more than 2 caplets in 24 hours
| adults and children 12 years of age and over | • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours |
| children under 12 years of age | • do not use |
• Store at room temperature between 20-25°C (68-77°F).
• avoid excessive heat, cold and humidity.
• close cap tightly after use.
colloidal silicon dioxide, croscarmellose sodium, FD&C blue No.1, hydroxy propyl methyl cellulose, magnesium stearate, starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.
1-833-665-9444. (Mon-Fri 9am-5pm)
ADULT
PAIN RELIEVER NIGHTTIME SLEEP AID
TAMPER EVIDENT: Do not use if imprinted safety seal under cap is broken or missing
Distributed By: O4 GLOBAL TRADING USA, LLC.
12222 Merit Drive, Suite 1900
Dallas, TX 75251-3209
Packaged By: Strive Pharmaceuticals Inc.
East Brunswick, NJ 08816.
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73006-120-95 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b288-d8a0-e053-dadaa90a6e4e | Only For ™ BODY PAIN |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73006-120-95 | Only For BODY PAIN | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 73006-120-95 | Only For BODY PAIN | 25 in 1 BOTTLE, PLASTIC | TABLET | 25 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73006-120 | 73006-120-95 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ec528ea0-2522-4f3b-87dd-0fd9efa639f2 | ff61406a-ca7c-4b8d-a730-8bdbceab0389 | 2020-11-19 | Warnings | ec528ea0-2522-4f3b-87dd-0fd9efa639f2 ff61406a-ca7c-4b8d-a730-8bdbceab0389 |
Adverse event summaries are temporarily unavailable. Other product information remains available.