Cold Head Congestion Severe (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) Dailymed
IMPRINT: 44 503
SHAPE: capsule
COLOR: yellow
All Imprints
{8 (acetaminophen 325 mg / chlorpheniramine maleate 2 mg / dextromethorphan hydrobromide 10 mg / phenylephrine hydrochloride 5 mg oral tablet) / 16 (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochlor - 44 503 oval yellow
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Active Ingredients (in Each Caplet)
Acetaminophen 325 mgDextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducerCough suppressantExpectorantNasal decongestion
Uses
temporarily relieves these common cold/flu symptoms:
headache
minor aches and pains
sore throat
nasal congestion
impulse to coughÂ
cough
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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
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.
Ask a doctor before use if you have
liver disease
diabetes
heart disease
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
When using this product
do not exceed recommended dosage.
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.Â
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
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
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 12 caplets in 24 hours
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
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
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
ColdHead CongestionSevereÂ
Pain Reliever/Fever ReducerNasal Decongestant, Cough SuppressantExpectorant
Headache, Sore Throat - AcetaminophenNasal Congestion - Phenylephrine HClCoughing - DextromethorphanChest 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 USAAC (870) 535-3635
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Select Brand 44-503C (Head Congestion)
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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