COLD MULTI-SYMPTOM, DAYTIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet
FRED'S, INC.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Freds Pharmacy 44-560
Active ingredients (in each gelcap)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these common cold/flu symptoms:
- headache
- sinus congestion and pressure
- nasal congestion
- cough
- sore throat
- minor aches and pains
- helps clear nasal passages
- promotes nasal and sinus drainage
- temporarily reduces fever
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
- 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:
- skin reddening
- blisters
- rash
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
- high blood pressure
- thyroid disease
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
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
- persistent cough lasts for more than one week , tends to recur, or is accompanied by fever, rash, or persistent headache
These could be signs of a serious condition.
Directions
- do not take more than directed
- adults and children 12 years and over
- take 2 gelcaps every 4 hours
- do not take more than 10 gelcaps in 24 hours
- children under 12 years: ask a doctor
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- avoid high humidity
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
croscarmellose sodium, crospovidone, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide
Principal Display Panel
fred's
Pharmacy
NDC 55315-560-08
Daytime Non-Drowsy
Cold
Multi-Symptom
Acetaminophen 325 mg - Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg - Cough Suppressant
Phenylephrine HCl 5 mg - Nasal Decongestant
• Fever • Headache • Coughing
• Sore Throat • Nasal Congestion
24 Rapid Release
Gelcaps
Actual Size
Compare to the active ingredients in:
Tylenol® COLD MAX day*
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com
100% satisfaction
guaranteed
Questions or comments? 1-855-331-FRED (3733)
*This product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the registered
trademark Tylenol® COLD MAX day.
50844 REV0216C56008
Freds pharmacy 44-560
| COLD
MULTI-SYMPTOM, DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet |
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| Labeler - FRED'S, INC. (005866116) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(55315-560) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | PACK(55315-560) | |