Label: COLDTAC ULTRA- acetaminophen 325mg, chlorpheniramine maleate 2mg, phenylephrine hcl 5mg tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 69729-142-06, 69729-142-72 - Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated January 5, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Purpose
-
USES
Tempporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- headache
- sinus congestion and pressure
- nasal congestion
- runny nose and sneezing
- minor aches and pains
Temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus openings and passages
- WARNINGS
- ALLERGY ALERT
-
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 dugs 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 a 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
- to make a child sleepy
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children
- Overdose warning
- Directions: do not take more than directed (see overdose warning)
- OTHER INFORMATION
- Inactive Ingredients
- Questions or comments? 619-600-5632
- COLDTAC ULTRA2 Tablets in a pouch
-
INGREDIENTS AND APPEARANCE
COLDTAC ULTRA
acetaminophen 325mg, chlorpheniramine maleate 2mg, phenylephrine hcl 5mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-142 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-142-06 3 in 1 PACKAGE 01/05/2018 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:69729-142-72 72 in 1 PACKAGE 01/05/2018 2 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/05/2018 Labeler - OPMX LLC (029918743) Establishment Name Address ID/FEI Business Operations Centurion Laboratories pvt. Ltd. 873229784 manufacture(69729-142) , analysis(69729-142) , pack(69729-142)
