Label: COLD TERMINATOR COLD RELIEF- phenylephrine hydrochloride, acetaminophen, dextromethorphan hydrobromide, guaifenesin tablet, film coated
- NDC Code(s): 84269-2556-1, 84269-2556-2
- Packager: Wildman Business Group
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 1, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
Temporarily relieves these symptoms due to the common cold:
- headache
- nasal congestion
- cough
- minor aches and pains
- sore throat
- sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive
Temporarily reduces fever.
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- blisters
- rash
- skin reddening
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 a doctor promptly.
DO NOT USE
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 have ever had an allergic reaction to this product or any of its ingredients
- 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.
ASK DOCTOR
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema
ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
STOP USE
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, cough, or nasal congestion 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.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL – 150 Tablet Box Label
-
INGREDIENTS AND APPEARANCE
COLD TERMINATOR COLD RELIEF
phenylephrine hydrochloride, acetaminophen, dextromethorphan hydrobromide, guaifenesin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84269-2556 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color orange (orange) Score no score Shape CAPSULE (Caplet) Size 17mm Flavor Imprint Code 44;546 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84269-2556-2 75 in 1 BOX 07/01/2024 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:84269-2556-1 50 in 1 BOX 07/01/2024 2 2 in 1 PACKET; 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 07/01/2024 Labeler - Wildman Business Group (016677338) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 MANUFACTURE(84269-2556) Establishment Name Address ID/FEI Business Operations Medique Products 086911794 PACK(84269-2556) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 PACK(84269-2556)
