NightTime Cold acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE D&C YELLOW NO. 10 EDETATE DISODIUM FD&C BLUE NO. 1 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE 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

NightTime Cold acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE D&C YELLOW NO. 10 EDETATE DISODIUM FD&C BLUE NO. 1 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE

Mfr: OTC
FunFoxMeds bottle

Drug Facts

Composition & Profile

Active Ingredients
Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Inactive Ingredients
Inactive ingredients citric acid D&C Yellow No. 10 disodium edetate FD&C Blue No. 1 flavor glycerin propyl gallate propylene glycol purified water sodium benzoate sodium chloride sodium citrate sorbitol sucralose
Strengths
650 mg 20 mg 12.5 mg 10 mg
Quantities
354 ml
Treats Conditions
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
Pill Appearance
Color: orange

Identifiers & Packaging

Container Type BOTTLE
Packaging

PRINCIPAL DISPLAY PANEL - 354mL Bottle Label *Compare to the active ingredients in VICKS ® NyQuil™ Severe + Vapo COOL™ NDC 0363-6140-12 NightTime Cold & Flu Relief Acetaminophen- Pain reliever/Fever reducer Dextromethorphan HBr – Cough suppressant Doxylamine Succinate - Antihistamine Phenylephrine HCl – Nasal decongestant For Relief of • Minor Aches & Pains, Fever • Nasal Congestion & Sinus Pressure • Sneezing, Runny Nose • Cough • Cough 12 FL OZ (354 ml) NightTime Cold & Flu Cold Relief

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 354mL Bottle Label *Compare to the active ingredients in VICKS ® NyQuil™ Severe + Vapo COOL™ NDC 0363-6140-12 NightTime Cold & Flu Relief Acetaminophen- Pain reliever/Fever reducer Dextromethorphan HBr – Cough suppressant Doxylamine Succinate - Antihistamine Phenylephrine HCl – Nasal decongestant For Relief of • Minor Aches & Pains, Fever • Nasal Congestion & Sinus Pressure • Sneezing, Runny Nose • Cough • Cough 12 FL OZ (354 ml) NightTime Cold & Flu Cold Relief

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 • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take • more than 4 doses 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. 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. Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema • trouble urinating due to enlarged prostate gland • a sodium-restricted diet Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin 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 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. 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 at 1-800-222-1222 . Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine 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.

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.

Storage & Handling

Other information • each 30 mL contains: sodium 81 mg • Store at roomtemperature. Do not refrigerate.

Questions

Questions? 1-866-467-2748


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