SEVERE COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquid

Severe cold and flu by

Drug Labeling and Warnings

Severe cold and flu by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCI 10 mg 

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal Decongestant

Uses

• temporarily relieves common cold/flu symptoms:
  • nasal congestion 
  • sore throat
  • headache
  • sinus congestion and pressure
  • minor aches and pain
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
• temporarily reduces
  • fever
  • cough to help you sleep
  • swelling of nasal passage
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday 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

• 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.
• with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

Ask a doctor before use if you have

• liver disease
• heart disease 
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• trouble urinating due to an enlarges prostate gland
• 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
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not use more than directed (see overdose warning)
• 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

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• new symptoms occur 
• fever gets worse or last more than 3 days
• redness or swelling is present
• cough comes back, or occurs with rash or headache that lasts.

These could be a signs of a serious conditions.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center  (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• take only as directed - see Overdose warning
• do not exceed 4 doses per 24 hours
• measure only with dosing cup provided. Do not use any other dosing device.
• mL = milliliter
• keep dosing cup with product
• adults and children 12 years and over: 30 mL every 4 hours
• children under 12 years of age: do not use
• When using Day Time or Night Time products, carefully read each label to ensure correct dosing.

Other information

• each 30 mL contains; sodium 64 mg
• store between 20-25ºC (68-77ºF). Do not refrigerate

Inactive ingredients

anhydrous citric acid. FD&C blue1, FD&C red 40, Flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum 

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL® SEVERE COLD & FLU*

NIGHTTIME

Severe Cold & Flu Relief

Acetaminophen 650 mg Pain Reliever/Fever Reducer

Dextromethorphan HBr 20 mg Cough Suppressant

Doxylamine Succinate 12.5 mg Antihistamine

Phenylephrine HCI 10 mg Nasal Decongestant

Relieves

• Headache, Fever, Sore Throat, Minor Aches & Pains
• Nasal/Sinus Congestion & Sinus Pressure
• Sneezing
• Runny Nose
• Cough

Alcohol Free

Max Strength

For Ages 12 Years & Over

BERRY

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company. 

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL  AROUND DOSAGE CUPOR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

10611 MONROE RD,

MATTHEWS, NC 28105

Product Label

FAMILY WELLNESS Nighttime Severe Cold & Flu Relief

INGREDIENTS AND APPEARANCE

SEVERE COLD AND FLU  NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-416
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-416-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/31/2015

Labeler - Family Dollar (FAMILY WELLNESS) (024472631)