![MULTI-SYMPTOM COLD FLU AND SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]](https://medic.hrt.org//dailymed/images/8165cab8-5e49-4a17-8c86-e057b218a7e7/equate-44-616-1.jpg)
| NDC | 49035-616-01, 49035-616-41 |
| Set ID | 8165cab8-5e49-4a17-8c86-e057b218a7e7 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Wal-Mart Stores 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
- 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
- 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 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
Ask a doctor before use if you have
- liver disease
- diabetes
- heart disease
- difficulty in urination due to enlargement of the prostate gland
- thyroid disease
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if
- new symptoms occur
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- 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?
-
Principal Display Panel
equate®
NDC 49035-616-01
Maximum Strength
Multi-Symptom
Cold, Flu &
Sore ThroatAcetaminophen 325 mg /
Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg /
Cough Suppressant
Guaifenesin 200 mg / Expectorant
Phenylephrine HCl 5 mg / Nasal Decongestant• Relieves Headache,
Fever & Sore Throat
• Controls Cough
• Thins & Loosens Mucus
• Relieves Nasal &
Chest CongestionFor Ages 12 and Over
30
CAPLETSActual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR
SHOWS ANY SIGNS OF TAMPERINGSatisfaction guaranteed - for questions
or comments please call 1-888-287-1915.Distributed by: Walmart Inc., Bentonville, AR 72716
50844 REV0419B61601
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
Equate 44-616
-
INGREDIENTS AND APPEARANCE
MULTI-SYMPTOM COLD FLU AND SORE THROAT MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-616 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) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:49035-616-01 3 in 1 PACKAGE 04/07/2013 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:49035-616-41 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 04/07/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/07/2013 Labeler - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(49035-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(49035-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(49035-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(49035-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(49035-616)