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| Product NDC Code | 55505-221 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Safetussin pm nighttime cough relief |
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| Type | Brand | ||||||
| Pharm Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 1115329 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | Kramer Laboratories | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each 5mL) Purpose Dextromethorphan HBr, USP 7.5 mg Cough Suppressant Doxylamine Succinate 3.125 mg Antihistamine
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions do not take more than 4 doses in any 24-hour period age dose adults and children 12 years and over 20 mL every 6 hours children under 12 years ask a doctor children under 4 years do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients : citric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, sucralose
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves cough runny nose and sneezing
Purpose
Information about the drug product’s indications for use.Active ingredients (in each 5mL) Purpose Dextromethorphan HBr, USP 7.5 mg Cough Suppressant Doxylamine Succinate 3.125 mg Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Safetussin PM Nighttime Cough relief Dextromethorphan HBr, Doxylamine Succinate CITRIC ACID MONOHYDRATE GLYCERIN MENTHOL, UNSPECIFIED FORM MINT PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE DEXTROMETHORPHAN DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE DOXYLAMINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES Safetussin ® PM NightTime Cough Relief Dextromethorphan HBr 7.5 mg / Cough Suppressant Doxylamine Succinate 3.125 mg / Antihistamine Safe for adults with High Blood Pressure Diabetes √ Controls Cough √ Relieves Sneezing √ Relieves runny nose SUGAR & ALCOHOL FREE 4.0 FL OZ (118mL) SEGURO PARA ADULTOS CON PRESION ALTA Y DIABETES Safetussin ® PM Alivia la Tos Durante la Noche Dextromethorphan HBr 7.5 mg / Antiusivo Doxylamine Succinate 3.125 mg / Antihistaminíco Seguro para adultos con Presión Alta Diabetes √ Calma la tos, √ Alivia estornudos √ Alivia goteo de la nariz SIN AZÚCAR Y SIN ALCOHOL 4 FL. OZ (118 mL) Safetussin ® PM NIGHT TIME COUGH RELIEF Cough Suppressant / Antihistamine Up To 8 Hours of cough relief to help you rest Safetussin ® PM contains: √ No decongestants √ No acetaminophen √ No sugar √ No alcohol √ No sorbitol √ No fructose √ No gluten √ No dyes Pharmacist Recommended Brand Always read and follow label directions. Do not use longer than 7 consecutive days unless directed by a doctor. Ask a doctor if you have individual health questions. Questions? Comments? Call 1-800-824-4894 © 2023 Kramer Laboratories, Inc. Bridgewater, NJ 08807 ● kramerlabs.com K0723 PACKAGE LABEL FOR 4 FL OZ (118 mL) Safetussin PM NightTime Cough Relief 4.0 FL OZ (118 mL) PACKAGE LABEL FOR 4 FL OZ (118 mL) Safetussin PM NightTime Cough Relief 8.0 FL OZ (237 mL)
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have asthma emphysema glaucoma excessive phlegm (mucus) breathing problem chronic bronchitis persistent or chronic cough cough associated with smoking trouble urinating due to enlarged prostate gland a sodium-restricted diet
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information: Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F) Save this package for complete information
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use 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 .to make a child sleep.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API