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NDC 68210-2000-02 VALUMEDS ASPIRIN FREE HEADACHE RELIEF PM 500; 38 mg/1; mg/1 Details
VALUMEDS ASPIRIN FREE HEADACHE RELIEF PM 500; 38 mg/1; mg/1
VALUMEDS ASPIRIN FREE HEADACHE RELIEF PM is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by SPIRIT PHARMACEUTICALS LLC. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 68210-2000-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 68210-2000-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 68210-2000 |
|---|---|
| Product ID | 68210-2000_ee03445d-01da-a710-e053-2995a90a57a2 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | VALUMEDS ASPIRIN FREE HEADACHE RELIEF PM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 500; 38 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE |
| Labeler Name | SPIRIT PHARMACEUTICALS LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 68210-2000-02 (68210200002)
| NDC Package Code | 68210-2000-2 |
|---|---|
| Billing NDC | 68210200002 |
| Package | 1 BOTTLE in 1 CARTON (68210-2000-2) / 20 TABLET, COATED in 1 BOTTLE |
| Marketing Start Date | 2018-04-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 27d83e0f-344a-4527-b86f-a8c7db33a585 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 2 caplets 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
- blisters
- rash
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
Do not use
- if you are allergic to acetaminophen
- 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
Ask a doctor before use if you have
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- avoid alcoholic drinks
- drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
Directions
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 20 COUNT BOTTLE CARTON
INGREDIENTS AND APPEARANCE
| VALUMEDS ASPIRIN FREE HEADACHE RELIEF PM
acetaminophen and diphenhydramine citrate tablet, coated |
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| Labeler - SPIRIT PHARMACEUTICALS LLC (179621011) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| ELYSIUM PHARMACEUTICALS LIMITED | 915664486 | manufacture(68210-2000) | |