Skip to Content

Sanaflu Nighttime Xtreme Multi Symptom Cold Flu Relief Cherry Flavor

Medically reviewed on Dec 21, 2017

Dosage form: liquid
Ingredients: ACETAMINOPHEN 650mg in 1mL, DEXTROMETHORPHAN HYDROBROMIDE 30mg in 1mL, DOXYLAMINE SUCCINATE 12.5mg in 1mL
Labeler: Grandall Distributing Co., Inc.
NDC Code: 48201-010

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Sanaflu Nighttime Xtreme Multi Symptom Cold Flu Relief Cherry Flavor

Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses
  • temporarily relieves these common cold/flu symptoms
  • minor aches and pains • headache • sore throat • runny nose and sneezing • fever • cough due to minor throat and bronchial irritation

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 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 • 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 

Ask a doctor or pharmacist before use if you are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product
  • 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
  • pain 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.

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 for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • 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 6 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information
  • each 30 mL contains: potassium 5 mg
  • each 30 mL contains: sodium 24 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

acesulfame potassium, alcohol, citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

Call 1-800-344-2422 Monday-Friday 8AM-5PM PST

Package Labeling:

SANAFLU NIGHTTIME XTREME MULTI SYMPTOM COLD FLU RELIEF CHERRY FLAVOR 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48201-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 1 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ALCOHOL 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
Packaging
#Item CodePackage Description
1NDC:48201-010-00237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/31/2017
Labeler - Grandall Distributing Co., Inc. (044428324)

 
Grandall Distributing Co., Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide