DG HEALTH COLD AND FLU RELIEF NITE TIME- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid 
Dolgencorp Inc

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.

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Dolgencorp, LLC Cold + Flu Relief Drug Facts

Active ingredients (in each 30 ml dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/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. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. 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

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is 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.
  • to make a child sleepy
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • 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

  • 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. 

In case of overdose, get medical help or contact a Poison Control Center right away. (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.

Directions

  • take only as directed – see Liver warning
  • use dose cup
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over30 ml (2 TBSP) every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other Information

  • each 30 ml dose cup contains: sodium 37 mg
  •   store at 20°- 25°C (68°- 77°F)

Inactive ingredients

alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

1-888-309-9030

Package/Label Principal Display Panel

Nite Time

Cold + Flu Relief

Pain Reliever/Fever Reducer: Acetaminophen

Cough Suppressant: Dextromethorphan HBr

Antihistamine: Doxylamine Succinate

Compare to active ingredients of NyQuil®

ALCOHOL 10%

Cold + Flu Relief Label Image 1

Cold + Flu Relief Label Image 1

Cold + Flu Relief Label Image 2

Cold + Flu Relief Label Image 2

DG HEALTH COLD AND FLU RELIEF  NITE TIME
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55910-335
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ANHYDROUS CITRIC ACID 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
FD&C YELLOW NO. 6 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM DIHYDRATE 
SODIUM CITRATE 
Product Characteristics
ColorGREEN (clear, bright green) Score    
ShapeSize
FlavorFRUIT (anise / cooling menthol aroma) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-335-38296 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/17/2011
Labeler - Dolgencorp Inc (068331990)

Revised: 5/2012
 
Dolgencorp Inc