![MUCUS RELIEF, COLD, FLU AND SORE THROAT MAXIMUM STRENGTH, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]](https://medic.hrt.org//dailymed/images/77cf8b01-e1a6-4d8d-b2ac-8feb1225a61f/cvp-44-616-1.jpg)
| NDC | 57243-616-03 |
| Set ID | 77cf8b01-e1a6-4d8d-b2ac-8feb1225a61f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Salado Sales, Inc. |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- with other drugs containing acetaminophen
- more than 4,000 mg of acetaminophen in 24 hours
- 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
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- high blood pressure
- liver disease
- diabetes
- heart disease
- thyroid disease
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
CVP®
HEALTHMAXIMUM STRENGTH
MULTI-SYMPTOMMUCUS RELIEF
COLD, FLU & SORE THROAT• ACETAMINOPHEN - PAIN RELIEVER/FEVER REDUCER
• DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT
• GUAIFENESIN - EXPECTORANT
• PHENYLEPHRINE HCl - NASAL DECONGESTANTRELIEVES:
HEADACHE
FEVER & SORE THROAT
NASAL CONGESTION
CHEST CONGESTION
CONTROLS COUGH
THINS & LOOSENS MUCUS10 CAPLETS
PSEUDOEPHEDRINE FREETAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV0419A61603
Distributed by Consumer Value Products, Inc.
P.O. Box 6115, Temple, Texas 76502
CVPproducts.com
44-616
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INGREDIENTS AND APPEARANCE
MUCUS RELIEF, COLD, FLU AND SORE THROAT MAXIMUM STRENGTH, MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57243-616 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color blue Score no score Shape OVAL Size 19mm Flavor Imprint Code 44;616 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57243-616-03 1 in 1 CARTON 04/07/2013 1 10 in 1 BLISTER PACK; 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 04/07/2013 Labeler - Salado Sales, Inc. (009830555) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(57243-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(57243-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(57243-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(57243-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(57243-616)