Label: COLDTAC PLUS- acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide tablet
- NDC Code(s): 69729-143-02, 69729-143-06, 69729-143-72
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 20, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
-
Uses
Temporarily
- Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- Relieves sinus congestion and pressure, helps decongest sinus openings and passages
- Restores freer breathing
- Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive
- Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
- Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps
-
Warnings:
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- More than 8 tablets in 24 hours
- With other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reactio 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 a doctor promptly
-
Do not use
- with any other product 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 presription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- for more than 7 days for pain and 3 days for fever, unless directed by a doctor
- Ask a doctor before use
- Ask a doctor or pharmacist
-
Stop use and ask a doctor if
- new symptoms occur
- redness or swelling is present
- pain or fever persists or gets worse
- nervousness, dizziness, or sleeplessness occur
- a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- If pregnant or breast-feeding,
- KEEP OUT OF REACH OF CHILDREN
- Directions:
- Other Information
- Inactive Ingredients
- Questions & comments?
-
SPL UNCLASSIFIED SECTION
NDC 69729-143-06
COLDTAC Plus
Tablets
Acetaminophen 325 mg / Guaifenesin 200 mg
Dextromethorphan HBr 15 mg / Phenylephrine HCl 5 mg
Effective and quick relief from
cough, cold & flu symptoms
Pain reliever, fever reducer
Nasal Decongestant
Cough Suppressant
Expectorant
Contents 12 Tablets
Exclusively distributed by OPMX
San Diego, CA 92154
Phone: 619-600-5632
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
COLDTAC PLUS
acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-143 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POVIDONE K30 (UNII: U725QWY32X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) CROSPOVIDONE (UNII: 2S7830E561) TALC (UNII: 7SEV7J4R1U) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score 2 pieces Shape CAPSULE Size 16mm Flavor Imprint Code A15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-143-06 6 in 1 PACKAGE 01/05/2018 1 NDC:69729-143-02 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:69729-143-72 72 in 1 PACKAGE 01/05/2018 2 NDC:69729-143-02 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 Drug M012 01/05/2018 Labeler - OPMX LLC (029918743)