COLD MULTI-SYMPTOM NIGHT-TIME- acetaminophen,chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci tablet 
Allegiant Health

----------

Drug Facts

Active ingredient

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant

Uses

temporarily relieves these common cold/flu symptoms:

Warnings

Liver warning/Allergy alert

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets

(3,250 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
  • with other drugs containing acetaminophen

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 immediately

Sore throat warning

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.
  • 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

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

When using this product

do not exceed recommended dosage.

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • pain, nasal congestion 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: In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Taking more than the recommended dose (overdose) may cause liver damage. 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 Warnings)

Adults and children 12 years and over:

Children under 12 years: ask a doctor

Other Information

Inactive Ingredients

corn starch, crospovidone, croscarmellose
sodium, FD&C blue #1 aluminum lake, hypromellose, magnesium
stearate, microcrystalline cellulose, povidone, pregelatinized starch,
polyethylene glycol, silicon dioxide, stearic acid, itanium dioxide

May contain: FD&C lake black

Questions or comments?

Call toll free 1-888-952-0050 Monday through Friday 

Package/Label Principal Display Panel

Cold Multi-symptom

Cold Multi-symptom

COLD MULTI-SYMPTOM  NIGHT-TIME
acetaminophen,chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-319
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CROSPOVIDONE (UNII: 2S7830E561)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code AZ319
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-319-8612 in 1 BLISTER PACK; Type 0: Not a Combination Product12/23/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/23/2014
Labeler - Allegiant Health (079501930)

Revised: 12/2018
Document Id: 2c10d41f-cfbb-48dc-851f-b2959d12e075
Set id: 3f020cf2-6011-4216-9b39-0b3dc5f0749c
Version: 5
Effective Time: 20181226
 
Allegiant Health