FDA Label for Poly-hist Dm
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE THIS PRODUCT
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF:
- IF PREGNANT OR BREAST FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS? COMMENTS?
- PRINCIPAL DISPLAY PANEL
Poly-hist Dm Product Label
The following document was submitted to the FDA by the labeler of this product Poly Pharmaceuticals, Inc.. 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.
Active Ingredients
(in each 5 mL teaspoonful)
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg
Thonzylamine HCl 25 mg
Purpose
Antitussive
Nasal Decongestant
Antihistamine
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- cough due to minor throat and bronchial irritation
- runny nose
- sneezing
- itching of the nose and throat
- itchy, watery eyes
- nasal congestion
- reduces swelling of nasal passages
Warnings
Do not exceed recommended dosage.
Do Not Use This Product
- 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
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- heart disease
- high blood pressure
- thyroid disease
- diabetes
Ask A Doctor Or Pharmacist Before Use If
you are taking sedatives or tranquilizers.
When Using This Product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If:
- cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
- nervousness, dizziness, or sleeplessness occur
- new symptoms occur
If Pregnant Or Breast Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Do not exceed recommended dosage.
| Adults and children 12 years of age and over: | 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor. |
| Children 6 to under 12 years of age: | 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. |
| Children 2 to under 6 years of age: | Consult a doctor. |
Other Information
Store at 59 ○- 86 ○F (15 ○ - 30 ○C)
Inactive Ingredients
Bubblegum Flavor, Citric Acid, Magnasweet, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol, Sucralose.
Questions? Comments?
Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon. - Fri. (8 a.m. to 5 p.m. CST).
Principal Display Panel
NDC 50991-220-16
Poly-Hist DM Liquid
Antitussive • Nasal Decongestant
Antihistamine
Bubblegum Flavor
16 fl oz (473 mL)
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