St Josephs 44-461-Delisted
Drug Labeling and Warnings
Drug Details [pdf]
MAXIMUM STRENGTH FLU HBP- acetaminophen, dextromethorphan hbr, chlorpheniramine maleate tablet, film coated
Bedrock Brands, LLC
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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St Josephs 44-461-Delisted
Active ingredients (in each tablet)
Acetaminophen 500 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 15 mg
Uses
- temporarily relieves:
- minor aches and pains
- headache
- cough
- sneezing
- runny nose
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 tablets 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
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
- trouble urinating due to an enlarged prostate gland
- liver disease
- cough that occurs with too much phlegm (mucus)
- glaucoma
- a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- pain 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: 2 tablets every 6 hours while symptoms persist. Do not take more than 8 tablets 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)
- protect from excessive moisture
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Principal Display Panel
NDC: 76000-461-08
ST. JOSEPH®
DECONGESTANT-FREE
HBP
COLD RELIEF for people with
High Blood Pressure
MAXIMUM
STRENGTH
FLU
Pain Reliever/Fever Reducer - Acetaminophen
Antihistamine - Chlorpheniramine maleate
Cough Suppressant - Dextromethorphan HBr
Relieves:
Body Aches, Pains and Headache
Fever Cough
Runny Nose
Actual Size
24 Tablets
REV0512A46108
Blister opening instructions:
Fold along perforations; peel back at arrows; push product through foil.
Distributed by:
St. Josephs Health Products, LLC
Baltimore, MD 21201
1-855-STJ-6381
www.stjosephaspirin.com
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
St. Jospeh 44-461
| MAXIMUM STRENGTH FLU HBP
acetaminophen, dextromethorphan hbr, chlorpheniramine maleate tablet, film coated |
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| Labeler - Bedrock Brands, LLC (829056162) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(76000-461) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(76000-461) | |
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