Cold Head Congestion Daytime by FRED'S, INC.
Medically reviewed on February 27, 2017
Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: FRED'S, INC.
NDC Code: 55315-047
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.
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
- temporarily relieves these common cold symptoms:
- minor aches and pains
- nasal congestion
- sore throat
- sinus congestion and pressure
- helps clear nasal passages
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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
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
- 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.
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- heart disease
- liver disease
- cough that occurs with too much phlegm (mucus)
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms appear
- 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.
ask a health professional before use.
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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not take more than directed
(see overdose warning)
- adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
- children under 12 years: ask a doctor
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86º)
- see end flap for expiration date and lot number
corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc, titanium dioxide
Headache/Sore Throat - Acetaminophen
Coughing - Dextromethorphan HBr
Nasal Congestion - Phenylephrine HCl
Compare To The Active Ingredients in Tylenol® Cold Head Congestion Daytime*
24 Cool Caplets
with Cool Blast Flavor
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 Daytime.
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
|COLD HEAD CONGESTION DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
|Labeler - FRED'S, INC. (005866116)|
|LNK International, Inc.||038154464||PACK(55315-047)|
|LNK International, Inc.||832867894||MANUFACTURE(55315-047)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.