FDA Label for Otis Clapp Valihist
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSES
- TEMPORARILY RELIEVES MINOR ACHES AND PAINS ASSOCIATED WITH
- TEMPORARILY RELIEVES NASAL CONGESTION DUE TO
- TEMPORARILY
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - OTIS CLAPP VALIHIST LABEL
- PRINCIPAL DISPLAY PANEL - MEDIQUE MEDICIDIN D LABEL
Otis Clapp Valihist Product Label
The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.
Adults and children (12 years and older): Take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours.
Children under 12 years: Do not give to children under 12 years of age.
Active Ingredients (In Each Tablet)
Acetaminophen 325 mg
Chlorpheniramine Maleate 2 mg
Phenylephrine Hydrochloride 5 mg
Purposes
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
Temporarily Relieves Minor Aches And Pains Associated With
- headache
- muscular aches
- minor arthritis pain
- common cold
- toothache
- menstrual cramps
Temporarily Relieves Nasal Congestion Due To
- common cold
- hay fever or other respiratory allergies
Temporarily
- reduces fever
- relieves runny nose and reduces sneezing, itching of the nose and throat and itchy, watery eyes due to hay fever
- promotes nasal and/or sinus drainage; relieves sinus congestion and pressure
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 tablets 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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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. - for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
- with any other drug using the above active 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.
Ask A Doctor Before Use If You Have
- liver disease
- thyroid disease
- diabetes
- high blood pressure
- heart disease
- glaucoma
- chronic bronchitis or emphysema
- difficulty in urination due to enlargement of the prostate gland
When Using This Product
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Stop Use And Ask A Doctor If
- symptoms do not improve within 7 days or are accompanied by a fever
- pain or fever persists or gets worse
- redness or swelling is present
- any new symptoms appear
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of 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.
Directions
- do not use more than directed
Other Information
- store at room temperature 59°-86°F (15°-30°C)
- tamper evident sealed packets
- do not use any opened or torn packets
- avoid excessive heat and humidity
Inactive Ingredients
corn starch, crospovidone*, hypromellose, maltodextrin*, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate*, stearic acid
*may contain.
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
Acetaminophen 325 mg,
Chlorpheniramine Maleate 2mg
Phenylephrine HCl 5 mg
Tear Out Along Perforation To Dispense
PROFESSIONAL HEALTHCARE
New Formula
300 TABLETS (150 PACKETS OF 2)
Principal Display Panel - Medique Medicidin D Label
Medique®
Medicidin-D
Cold and Allergy Relief
Pull to Open
Pain Reliever/ Fever Reducer ● Acetaminophen 325mg
Antihistamine ● Chlorpheniramine Maleate 2mg
Nasal Decongestant ● Phenylephrine HCl 5mg
200Tablets
(100 x 2)
Tamper Evident Unit Dose Packets
* Please review the disclaimer below.