TCR - 1162 - 2022-1208
SPL UNCLASSIFIED SECTION
COLD + HEAD CONGESTION DAY
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- for the temporary relief of the following cold symptoms: minor aches and painsheadachesore throatnasal congestioncoughsinus congestion and pressure
- helps clear nasal passages
- temporarily reduces fever
SPL UNCLASSIFIED SECTION
COLD + HEAD CONGESTION NIGHT
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Chlorpheniramine maleate 2 mg | Antihistamine |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- for the temporary relief of the following cold symptoms: minor aches and painsheadachesore throatnasal congestionrunny nose and sneezingcoughsinus congestion and pressure
- helps clear nasal passages
- relieves cough to help you sleep
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) 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
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
- skin reddening
- blisters
- rash
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 taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
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
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
In addition, when using Cold + Head Congestion Night:
- do not exceed recommended dosage
Stop use and ask a doctor if
These could be signs of a serious condition.
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
| adults and children 12 years and over | take 2 caplets every 4 hoursswallow whole – do not crush, chew, or dissolve |
| children under 12 years | ask a doctor |
- do not take more than directed (see overdose warning)
- do not take Day and Night caplets at the same time
- do not take more than a total of 10 caplets in 24 hours
Other information
- store between 20-25°C (68-77°F) in a dry place
- retain carton for complete product information and warnings
Inactive ingredients
Cold + Head Congestion Day
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
Cold + Head Congestion Night
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide