COLD HEAD CONGESTION SEVERE- acetaminophen, dextromethorphan hbr, phenylephrine hcl and guaifenesin tablet, film coated
L&R Distributors, 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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Select Brand 44-503C-HC-Delisted
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Uses
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temporarily relieves these common cold/flu symptoms:
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headache
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minor aches and pains
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sore throat
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nasal congestion
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impulse to cough
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cough
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helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 caplets 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
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
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with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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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 a doctor before use if you have
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liver disease
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diabetes
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heart disease
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high blood pressure
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thyroid disease
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trouble urinating due to an enlarged prostate gland
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persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
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nervousness, dizziness, or sleeplessness occur
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pain, nasal congestion, or cough gets worse or lasts more than 7 days
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new symptoms occur
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fever gets worse or lasts more than 3 days
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redness or swelling is present
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cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
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do not take more than directed
(see overdose warning) -
adults and children 12 years and over
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take 2 caplets every 4 hours
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swallow whole - do not crush, chew, or dissolve
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do not take more than 12 caplets in 24 hours
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children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Other information
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store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
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see end flap for expiration date and lot number
Inactive ingredients
corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Principal Display Panel
NDC 15127-964-24
select brand®
the lower price name brand
Cold
Head Congestion
Severe
Pain Reliever/Fever Reducer
Nasal Decongestant, Cough Suppressant
Expectorant
Headache, Sore Throat - Acetaminophen
Nasal Congestion - Phenylephrine HCl
Coughing - Dextromethorphan
Chest Congestion - Guaifenesin
*Compare to the active ingredients of Tylenol® Cold Head Congestion Severe Daytime
24 COOL CAPLETS
with Cool Blast Flavor
Daytime
Non-Drowsy
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Head Congestion Severe Daytime.
50844 REV0512C50308
Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603 USA
AC (870) 535-3635
Select Brand 44-503C (Head Congestion)
| COLD HEAD CONGESTION SEVERE
acetaminophen, dextromethorphan hbr, phenylephrine hcl and guaifenesin tablet, film coated |
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| Labeler - L&R Distributors, Inc. (012578514) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(15127-964) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(15127-964) | |