COLDTAC PLUS- acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide tablet 
Healthlife of USA

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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COLDTAC Plus

Drug Facts 

Active Ingredients (in each tablet)

Acetaminophen USP 325mg.........................................................Pain reliever/fever reducer

Guaifenesin USP 200mg..............................................................Expectorant

Phenylephrine HCL USP 5mg........................................................Decongestant 

Dextromethorphan HBr USP 15mg................................................Antitussive

Purpose 

Pain reliever/  fever reducer

Expectorant

Decongestant

Antitussive

Uses

Temporarily

Warnings: Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert:

Acetaminophen may cause severe skin reactions. Symproms may include: skin reddening, blisters, rash if a skin reaction occurs, stop use and seek medical help right away.

Do not

Stop use and ask a doctor if:

symptoms do not improve, pain or fever persists or gets worse, new symptoms occur, redness or swelling is present, symptoms do not improve within 7 days or are accompanied by fever, cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

Ask a doctor before use if you have:

heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, liver disease 

Ask a doctor or pharmacist if you are

taking the blood thinning drug warfarin.

Do not exceed recommended dosage

if nervousness, dizziness, or sleeplessness occur, discontinue use consult a doctor.

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. Prompt medical attention is critical for adults as well as for children even if you do not nnotice any signs or symptoms

Directions:

Adults and children 12 years of age and older: Take 2 tablets every 6 to 8 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor. Children under 12 years, consult a doctor 

Other Inforamtion:

Inactive Ingredients

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid 

(*may contain)

Questions or comments? 

Call: 619-600-5632 (Mon-Fri 9am - 5pm EST)

COLDTAC Plus
2 Tablets in a pouch

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COLDTAC PLUS 
acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-143
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScore2 pieces
ShapecapsuleSize16mm
FlavorImprint Code A15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69517-143-063 in 1 PACKAGE10/02/2017
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:69517-143-7236 in 1 PACKAGE10/02/2017
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/02/2017
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIBusiness Operations
Centurion Laboratories Pvt Ltd873229784manufacture(69517-143) , analysis(69517-143) , pack(69517-143)

Revised: 10/2017
Document Id: 883a0468-8bc4-47bf-ace1-ab2d7935e398
Set id: c76704a6-b111-4252-ab10-48e2de450e78
Version: 1
Effective Time: 20171002
 
Healthlife of USA