![MULTI-SYMPTOM COLD FLU AND SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [FAMILY DOLLAR SERVICES INC]](https://medic.hrt.org//dailymed/images/9ffa3a29-0e19-4c6b-abee-7f76071990d9/family-wellness-44-616-1.jpg)
| NDC | 55319-616-09 |
| Set ID | 9ffa3a29-0e19-4c6b-abee-7f76071990d9 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Family Dollar Services Inc |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hours, which is the maximum daily amount
- 3 or more alcoholic drinks every day while using this product
- with other drugs containing acetaminophen
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
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- heart disease
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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?
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Principal Display Panel
MAXIMUM STRENGTH
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERINGCOMPARE TO THE ACTIVE INGREDIENTS
IN MAXIMUM STRENGTH MUCINEX®
FAST-MAX® COLD, FLU & SORE THROAT*
FAMILY
wellness™100% SATISFACTION
GUARANTEED
OR YOUR MONEY BACKMAXIMUM 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+
20 CAPLETS
Actual Size
OTC
networkDISTRIBUTED BY:
MIDWOOD BRANDS, LLC
10611 MONROE RD.
MATTHEWS, NC 28105*This product is not manufactured or distributed by
Reckitt Benckiser LLC, owner of the registered
trademark Maximum Strength Mucinex®
FAST-MAX® Cold, Flu & Sore Throat.50844 REV0117A61609
NOT 100% SATISFIED?
Return package and unused product
within 30 days to any Family Dollar store
for a refund (with receipt) or exchange.
Family Wellness 44-616
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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:55319-616 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 (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) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) 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:55319-616-09 2 in 1 PACKAGE 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 - Family Dollar Services Inc (024472631) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(55319-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(55319-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(55319-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(55319-616) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(55319-616)