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Night Time Cold and Flue Relief

Medically reviewed on March 5, 2018

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: Allegiant Health
NDC Code: 69168-357

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.

Drug Facts

Active ingredient

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever, runny nose and sneezing

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 productwith other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

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 products 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 drugs. 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

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

When using this product

do not exceed recommended dosage excitability may occur, especially in childrenmarked drowsiness may occur avoid alcoholic drink 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 last 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 accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose can cause serious health problems. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

■ take only as recommended (see Warnings)
■ do not exceed 4 doses per 24 hours
Adults and children 12 years and over: ■ take 2 softgels with water every 6 hours
Children 4 to under 12 years: ■ Ask a doctor
Children under 4 years: ■ Do not use

Other information

store at room temperature do not use if blister is torn or open

Inactive Ingredients

FD&C Green #3, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol. May also contain FD&C Blue #1, D&C Yellow Yellow #10, titanium dioxide.

Questions or comments

Call toll free 1-888-952-0050

Package/Label Principal Display Panel
NIGHT TIME COLD AND FLUE RELIEF 
acetaminophen, dextromethorphan, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-357
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C GREEN NO. 3 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize21mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-357-298 CAPSULE, LIQUID FILLED in 1 BOX
2NDC:69168-357-5120 CAPSULE, LIQUID FILLED in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/03/2015
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930LABEL(69168-357), MANUFACTURE(69168-357), PACK(69168-357), RELABEL(69168-357), REPACK(69168-357)

 
Allegiant Health

Further information

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

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