{"active_ingredient":["Active ingredients (in each 5mL) Purpose Dextromethorphan HBr, USP 7.5 mg Cough Suppressant Doxylamine Succinate 3.125 mg Antihistamine"],"active_ingredient_table":["
Active ingredients (in each 5mL)Purpose
Dextromethorphan HBr, USP 7.5 mgCough Suppressant
Doxylamine Succinate 3.125 mgAntihistamine
"],"ask_doctor":["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":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"dosage_and_administration":["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"],"dosage_and_administration_table":["
agedose
adults and children 12 years and over20 mL every 6 hours
children under 12 yearsask a doctor
children under 4 yearsdo not use
"],"effective_time":"20251229","id":"b7fd290f-7f8e-430f-8bbf-b5aeea4181de","inactive_ingredient":["Inactive ingredients : citric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, sucralose"],"indications_and_usage":["Uses temporarily relieves cough runny nose and sneezing"],"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."],"openfda":{"application_number":["M012"],"brand_name":["Safetussin PM Nighttime Cough relief"],"generic_name":["DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Kramer Laboratories"],"nui":["N0000181821","N0000182149","N0000181819","N0000182147"],"package_ndc":["55505-221-33","55505-221-36"],"pharm_class_epc":["Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]","Sigma-1 Agonist [EPC]"],"pharm_class_moa":["Uncompetitive NMDA Receptor Antagonists [MoA]","Sigma-1 Receptor Agonists [MoA]"],"product_ndc":["55505-221"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115329"],"spl_id":["b7fd290f-7f8e-430f-8bbf-b5aeea4181de"],"spl_set_id":["33dd2245-9abd-4b32-ac76-0f45a54c0f33"],"substance_name":["DEXTROMETHORPHAN","DOXYLAMINE SUCCINATE"],"unii":["7355X3ROTS","V9BI9B5YI2"]},"package_label_principal_display_panel":["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)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 5mL) Purpose Dextromethorphan HBr, USP 7.5 mg Cough Suppressant Doxylamine Succinate 3.125 mg Antihistamine"],"purpose_table":["
Active ingredients (in each 5mL)Purpose
Dextromethorphan HBr, USP 7.5 mgCough Suppressant
Doxylamine Succinate 3.125 mgAntihistamine
"],"set_id":"33dd2245-9abd-4b32-ac76-0f45a54c0f33","spl_product_data_elements":["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"],"stop_use":["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."],"storage_and_handling":["Other information: Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F) Save this package for complete information"],"version":"4","warnings":["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."],"when_using":["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"]}