DAYTIME COLD MULTI-SYMPTOM- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled
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 gelcap)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- nasal congestion
- cough
- sore throat
- sinus congestion and pressure
- 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 12 gelcaps 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 comiting, 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, 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 sgins 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 gelcaps every 4 hours
- do not take more than 12 gelcaps in 23 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
croscarmellose sodium, crospovidone, D&C red #28, FD&C blue #1, FD&C red #40, 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, sillica gel, stearic acid, titanium dioxide
Principal Display Panel
NDC 0363-0560-07 Compare to Tylenol® Cold Multi-Symptom Daytime active ingredients*
Walgreen
BONUS
24+12=36
Cold DAYTIME Non-Drowsy
Multi-Symptom
Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant
Fever, Headache, Sore Throat • Acetaminophen
Nasal Congestion • Phenylephrine HCl
Coughing • Dextromethorphan HBr
SEE NEW WARNINGS INFORMATION
Pseudoephedrine Free
36 GELCAPS
Fast Release
QUICK GELS ™
*This product is not manufactured or distributed by McNeil Consumer Healthcare., owner of the registered trademark Tylenol® Cold Mutli-Symptom Daytime.
50844 ORG100956008
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Walgreens 44-560
| DAYTIME COLD MULTI-SYMPTOM
acetaminophen, phenylephrine hcl and dextromethorphan hbr capsule, liquid filled |
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| Labeler - WALGREEN CO. (008965063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 038154464 | PACK(0363-0560) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 832867894 | MANUFACTURE(0363-0560) | |