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NDC 47682-0543-99 Otis Clapp Valihist 325; 2; 5 mg/1; mg/1; mg/1 Details
Otis Clapp Valihist 325; 2; 5 mg/1; mg/1; mg/1
Otis Clapp Valihist is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. The primary component is ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE.
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: 47682-0543-99Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine 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: 47682-0543-99Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 47682-0543-99Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 47682-0543 |
|---|---|
| Product ID | 47682-543_da833cb5-92ec-28a6-e053-2995a90a8315 |
| 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 | Otis Clapp Valihist |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 325; 2; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Unifirst First Aid Corporation |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 47682-0543-99 (47682054399)
| NDC Package Code | 47682-543-99 |
|---|---|
| Billing NDC | 47682054399 |
| Package | 2 TABLET, FILM COATED in 1 PACKET (47682-543-99) |
| Marketing Start Date | 2008-12-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1f172d58-4050-424b-9743-130d8e618fe8 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses
Temporarily relieves
- minor aches and pains
- headache
- nasal congestion
- sinus congestion and pressure
- runny nose
- sneezing
Temporarily
- reduces fever
- relieves runny nose and reduces sneezing, itching of the nose and throat and itchy, watery eyes due to hay fever
- helps clear nasal and/or sinus passages
SPL UNCLASSIFIED SECTION
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
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
SPL UNCLASSIFIED SECTION
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.
- for more than 10 days for pain unless directed by a doctor
- if you ever had an allergic reaction to this product or any of its ingredients
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Principal Display Panel - Otis Clapp Valihist Label
Otis Clapp
Quality and Integrity Since 1840
VALIHIST ™
Decongestant-Antihistamine
Pain Reliever-Fever Reducer
Antihistamine- Decongestant
For Allergies, Colds, Runny Nose
See Warnings and Directions on Side Panel
This Package is for Households without Young Children.
Acetaminophen 325 mg,
Chlorpheniramine Maleate 2mg
Phenylephrine HCl 5 mg
Tear Out Along Perforation To Dispense
PROFESSIONAL HEALTHCARE
300 TABLETS (150 PACKETS OF 2)
Principal Display Panel - Medique Medicidin D Label
INGREDIENTS AND APPEARANCE
| OTIS CLAPP VALIHIST
acetaminophen,chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated |
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| MEDIQUE MEDICIDIN D
acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated |
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| Labeler - Unifirst First Aid Corporation (832947092) |