COLD AND FLU NON DROWSY DAY RELIEF AND NIGHT RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
Gobrands, Inc
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COLD & FLU NON-DROWSY DAY RELIEF
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
COLD & FLU NIGHT RELIEF
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
COLD & FLU NON DROWSY DAY RELIEF
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
COLD & FLU NIGHT RELIEF
Pain reliever/fever reducer
Cough suppressant
Antihistamine
temporarily relieves common cold/flu symptoms:
Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: ● more than 4 doses in 24 hours, which is the
maximum daily amount for this product ● 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: ● skin reddening ● blisters ● rash
If a skin reaction occurs, stop use and seek medical help right away.
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.
● 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● to make a child sleepy (Nighttime only)
● cough that occurs with too much phlegm (mucus) ● liver disease
● trouble urinating due to enlarged prostate gland
● diabetes (Daytime only) ● heart disease (Daytime only)
● thyroid disease (Daytime only) ● high blood pressure (Daytime only)
● persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
● a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
● glaucoma (Nighttime only)
● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers (Nighttime only)
● do not take more than directed
● marked drowsiness may occur (Nighttime only)
● avoid alcoholic drinks (Nighttime only)
● excitability may occur, especially in children (Nighttime only)
● be careful when driving a motor vehicle or operating machinery (Nighttime only)
● alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
● you get nervous, dizzy or sleepless (Daytime only)
● pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
● pain or cough gets worse or lasts more than 7 days (Nighttime only)
● 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
These could be signs of a serious condition.
● when using other DAYTIME and NIGHTTIME products, carefully read each
label to ensure correct dosing
Directions (Daytime only)
● take only as directed - see Overdose warning
● do not exceed 4 doses per 24 hours
adults & children 12 years & over | take 2 softgels with water every 4 hours |
children 4 to under 12 years | ask a doctor |
children under 4 years of age | do not use |
● when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing
Directions (Nighttime only)
● take only as directed - see Overdose warning
● do not exceed 4 doses per 24 hours
adults & children 12 years & over | take 2 softgels with water every 6 hours |
children 4 to under 12 years | ask a doctor |
children under 4 years of age | do not use |
DAY RELIEF
FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide*, MYGLYOL 812*, lecithin*
*May Contain one or more of these ingredients
NIGHT RELIEF
D&C Yellow# 10, FD&C Blue# 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, polysorb*, sorbitol 70% solution*, titanium dioxide*, MYGLYOL 812*, lecithin*,
*May Contain one or more of these ingredients
COLD AND FLU NON DROWSY DAY RELIEF AND NIGHT RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit |
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Labeler - Gobrands, Inc (057499049) |
Registrant - Spirit Pharmaceuticals LLC (179621011) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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MEDGEL PRIVATE LIMITED | 677385498 | manufacture(82501-1579) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Elysium Pharmaceuticals Ltd | 863182240 | manufacture(82501-1579) |