ROBITUSSIN PEAK COLD NIGHTTIME NASAL RELIEF- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Richmond Division of Wyeth
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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Robitussin Peak Cold Nighttime Nasal Relief
[acetaminophen, chlorpheniramine maleate, and phenylephrine HCl]
USES
- temporarily relieves these symptoms associated with a cold, or flu:
- headache
- nasal congestion
- sore throat
- fever
- minor aches and pains
- temporarily relieves minor aches, pains and headache as well as these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- nasal congestion
- itching of the nose or throat
- itchy, watery eyes
- temporarily relieves minor aches, pains, headache and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages
WARNINGS
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 tablets in any 24-hour period, 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 vomiting, consult a doctor promptly.
Do not use
- to sedate a child or to make a child sleepy
- 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem such as emphysema, asthma, or chronic bronchitis
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking any other oral nasal decongestant or stimulant
- taking any other pain reliever/fever reducer
- taking sedatives or tranquilizers
When using this product
- do not use more than directed
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
DIRECTIONS
- do not use more than 12 tablets in any 24-hour period
- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage
- this adult product is not intended for use in children under 12 years of age
| age | dose |
|---|---|
| adults and children 12 years and over | 2 tablets every 4 hours |
| children under 12 years | do not use |
INACTIVE INGREDIENTS
calcium stearate, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid
PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Robitussin PEAK COLD NIGHTTIME Nasal Relief
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
CHLORPHENIRAMINE MALEATE (Antihistamine)
PHENYLEPHRINE HCl (Nasal Decongestant)
- Nasal Congestion
- Headache
- Sore Throat
- Runny Nose
Tablets individually blister sealed. If seal is broken, Do Not Use.
For most recent product information, visit www.robitussin.com
| ROBITUSSIN PEAK COLD NIGHTTIME NASAL RELIEF
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet |
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| Labeler - Richmond Division of Wyeth (829390835) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| PF Consumer Healthcare Canada ULC | 203812479 | ANALYSIS(0031-8732) , LABEL(0031-8732) , MANUFACTURE(0031-8732) , PACK(0031-8732) | |