Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

k">

NIGHT TIME COLD AND FLUE RELIEF- acetaminophen, dextromethorphan, doxylamine succinate capsule, liquid filled 
Allegiant Health

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 (in each softgel)

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 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 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 put a child to 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 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 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 blue #1, FD&C yellow #10, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Package/Label Principal Display Panel

Health A2Z 357

Health A2Z 357

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize21mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69168-357-298 in 1 BOX; Type 0: Not a Combination Product03/03/2015
2NDC: 69168-357-5120 in 1 BOX; Type 0: Not a Combination Product03/03/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/03/2015
Labeler - Allegiant Health (079501930)
Establishment
NameAddressID/FEIBusiness Operations
Allegiant Health079501930ANALYSIS(69168-357) , LABEL(69168-357) , MANUFACTURE(69168-357) , PACK(69168-357)

Revised: 12/2018
 
Allegiant Health


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.