DAYTIME COLD MULTI-SYMPTOM SEVERE- acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet, coated
WALGREEN CO.
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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Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenyleprhine HCl 5 mg
Uses
- temporarily relieves these common cold/flu symptoms
- minor aches and pains
- headache
- nasal congestion
- sore throat
- impulse to cough
- 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 for 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
- 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)
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.
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 controlled room temperature 15º-30ºC (59º-86ºF)
- 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 0363-0503-07
Walgreens
Compare to Tylenol® Cold Multi-Symptom Severe Daytime Caplets active ingredients*
BONUS
24+12=36
COLD DAYTIME
MULTI-SYMPTOM
Pain reliever, fever reducer, nasal decongestant, cough suppressant & antihistamine
SEVERE
PSEUDOEPHEDRINE FREE
Fever, Headache, Sore Throat - Acetaminophen
Nasal Congestion - Phenylephrine HCl
Coughing - Dextromethorphan HBr
Runny Nose - Chlorpheniramine maleate
36 CAPLETS
WITH COOL BLAST FLAVOR
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Multi-Symptom Severe Daytime Caplets.
50844 REV0111B50307
Distributed by: Walgreen Co.,
200 Wilmot Rd., Deerfield, IL 60015-4616
TAMPER EVIDENT: DO NOT USE IF THE CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Walgreen 44-503C
| DAYTIME COLD MULTI-SYMPTOM SEVERE
acetaminophen, phenylephrine hcl, dextromethorphan hbr and guiafenesin tablet, coated |
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| Labeler - WALGREEN CO. (008965063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 038154464 | PACK(0363-0503) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 832867894 | MANUFACTURE(0363-0503) | |