NightTime Relief Severe Cold and Flu acetaminophen, doxylamine succinate, phenylephrine hcl and dextromethorphan hbr ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM Prosweet
Drug Facts
Composition & Profile
Identifiers & Packaging
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle) fred's Pharmacy NDC 55315-365-31 MAXIMUM STRENGTH NIGHTTIME RELIEF SEVERE Cold & Flu Each dose (per 30 mL) (2 TBSP) of oral solution contains: 650 mg - Acetaminophen USP (Pain reliever/Fever reducer) 10 mg – Phenylephrine HCl USP (Nasal decongestant) 12.5 mg - Doxylamine succinate USP (Antihistamine) 20 mg - Dextromethorphan HBr USP (Cough suppressant) Headache, Fever, Sore Throat, Minor Aches & Pains Nasal/Sinus Congestion & Sinus Pressure Sneezing, Runny Nose Cough Berry Flavor 12 FL OZ (354 mL) Compare To Vicks ® Nyquil ® SEVERE COLD & FLU RELIEF * PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle) fred's Pharmacy NDC 55315-365-31 MAXIMUM STRENGTH NIGHTTIME RELIEF SEVERE Cold & Flu Each dose (per 30 mL) (2 TBSP) of oral solution contains: 650 mg - Acetaminophen USP (Pain reliever/Fever reducer) 10 mg – Phenylephrine HCl USP (Nasal decongestant) 12.5 mg - Doxylamine succinate USP (Antihistamine) 20 mg - Dextromethorphan HBr USP (Cough suppressant) Headache, Fever, Sore Throat, Minor Aches & Pains Nasal/Sinus Congestion & Sinus Pressure Sneezing, Runny Nose Cough Berry Flavor 12 FL OZ (354 mL) Compare To Vicks ® Nyquil ® SEVERE COLD & FLU RELIEF * PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)
Overview
Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage
Indications & Usage
Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage
Dosage & Administration
Directions take only as directed – see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours mL = milliliter; TBSP = tablespoon adults & children 12 years & over 30 mL (2 TBSP) every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses (120 mL) in 24 hours, which is the maximum daily amount for this product 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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Purpose
Active ingredients (in each 30 mL dose cup) Purpose Acetaminophen USP 650 mg .............................................. Pain reliever/fever reducer Dextromethorphan HBr USP 20 mg ............................................... Cough suppressant Doxylamine succinate USP 12.5 mg ........................................................ Antihistamine Phenylephrine HCl USP 10 mg ...................................................... Nasal decongestant
Do Not Use
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. 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
Stop Use & Ask a Doctor
Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Keep Out of Reach of Children
Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Storage & Handling
Other information each 30 mL dose cup contains: sodium 95 mg store at 20° to 25°C (68° to 77°F)
Questions
Questions or Comments? 1-855-274-4122 DISTRIBUTED BY: fred's Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118 www.fredsinc.com
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