ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet 
OPMX LLC

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 Ultra tabs
(Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)

Acetaminophen 500mg

Chlorpheniramine Maleate 4mg

Phenylephrine HCl 10mg

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

Adults and children 12 years of age & over1 tablet with water every 4-6 hours as needed
Children 4 to 12 years of ageAsk a doctor
Children under 4 years of ageDo not use

Temporarily relieves these symptoms of hay fever or other respiratory allergies:

Temporarily relieves these additional symptoms of hay fever:

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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 doctor promptly

Do not use:

Ask a doctor before use if you have:

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if:

You get nervous, dizzy, or sleepless
Pain, nasal congestion, 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

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.

Keep out of reach of children.

OVERDOSE WARNING: Read directions carefully. 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 notice any signs or symptoms.

store at room temperature between 20-25°C (68-77ºF)

avoid excessive heat and humidity

273738

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-122
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (BICONVEX) Size13mm
FlavorImprint Code S78
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-122-272 in 1 POUCH; Type 0: Not a Combination Product08/26/2019
2NDC:69729-122-3712 in 1 POUCH; Type 0: Not a Combination Product08/26/2019
3NDC:69729-122-38144 in 1 POUCH; Type 0: Not a Combination Product08/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/26/2019
Labeler - OPMX LLC (029918743)

Revised: 11/2020
Document Id: b373ab6d-2d73-2c15-e053-2a95a90a6012
Set id: b373a3a8-68c4-0187-e053-2995a90aad62
Version: 1
Effective Time: 20201106
 
OPMX LLC