DAYTIME MULTI-SYMPTOM COLD RELIEF- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride tablet
Major Pharmaceuticals
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
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. Sever liver damagae may occur if you take:
- more than 12 caplets in 24 hours, which is the maxiumum 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 using 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, 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 appear
- fever gets worse or lasts more than 3 days
- redness or swelling is presesnt
- 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, cheew, 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 severe liver damage
Other information
- store at controlled room temperature 15º-30ºC (59º-86º)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc, titanium dioxide
Principal display panel
Major®
See New Warnings Information
NDC 0904-5786-24
MULTI-SYMPTOM
Mapap®
COLD FORMULA
CAPLETS
ASPIRIN FREE
ACETAMINOPHEN
DEXTROMETHORPHAN HBr
PHENYLEPHRINE HCl
DAYTIME • NON-DROWSY
Pain Reliever / Fever Reducer
Cough Suppressant • Nasal Decongestant
For Fast Relief of: Fever, Headache, Sore Throat, Nasal Congestion, Coughing
24 CAPLETS with Cool Blast Flavor
Compare to active ingredients in TYLENOL® Cold Multi-Symptom Daytime*
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 Multi-Symptom Daytime. 50844 REV0810C47008
Distributed by MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA M-17 Rev.01/11
Re-order No. 006363
44-470C
| DAYTIME MULTI-SYMPTOM COLD RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet |
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| Labeler - Major Pharmaceuticals (191427277) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 038154464 | PACK(0904-5786) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 832867894 | MANUFACTURE(0904-5786) | |