Equaline 44-470C473-Delisted
Drug Labeling and Warnings
Drug Details [pdf]
HEAD CONGESTION DAYTIME AND NIGHTTIME COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl
SUPERVALU INC.
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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Equaline 44-470C473-Delisted
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine 5 mg
Uses
- temporarily relieves these common cold symptoms:
- minor aches and pains
- headache
- nasal congestion
- cough
- sore throat
- sinus congestion and pressure
- helps clear nasal passages
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophnen) in 24 hours. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- 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 taking a monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkison'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
- 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 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 use 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: ask a doctor
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polytheylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc, titanium dioxide
Active ingredients (in each caplet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine 5 mg
Uses
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- nasal congestion
- cough
- sore throat
- sinus congestion and pressure
- sneezing and runny nose
- helps clear nasal passages
- relieves cough to help you sleep
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophnen) in 24 hours. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- 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 taking a monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkison"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
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- persistent or chronic cough such as occurs with smoking, asthma, 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
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
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 use 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 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyetheylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Principal Display Panel
equaline®
compare to Tylenol® Cold Head Congestion Day and Night Caplets active ingredients**
NDC: 41163-529-08
head congestion
daytime & nighttime cold
daytime formula
non-drowsy
contains 3 medicines:
headache/sore throat > acetaminophen
coughing > dextromethorphan HBr
nasal congestion > phenylephrine HCl
nighttime formula
contains 4 medicines:
headache/sore throat > acetaminophen
runny nose > chlorpheniramine maleate
coughing > detromethorphan HBr
nasal congestion > phenylephrine HCl
*antihistamine in nighttime only
pain reliever, nasal decongestant, cough suppressant, *antihistamine
24 cool caplets with cool blast flavor
12 daytime & 12 nighttime
pseudoephedrine free
DOES NOT CONTAIN GLUTEN
**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of registered trademark Tylenol® Cold Head Congestion Daytime & Nighttime. 50844 REV0113.470/473B08
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING
Equaline 44-470C473
| HEAD CONGESTION DAYTIME AND NIGHTTIME COLD
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit |
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| Labeler - SUPERVALU INC. (006961411) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(41163-164) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(41163-164) | |