SEVERE COLD AND COUGH NIGHT TIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
Severe Cold and Cough by
Drug Labeling and Warnings
Severe Cold and Cough by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL). Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients (in each 30 mL)
- Purposes
- Uses
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Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:
- skin reddening
- blisters
- rash
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses (12 tablespoons or 180 mL) 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
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 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 product containing diphenhydramine, even one used on skin
- with any other product containing acetaminophen (prescription or non-prescription). 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
- glaucoma
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- cough accompanied by excessive phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are taking
- the blood thinning drug warfarin
- sedatives or tranquilizers
When using this product
- do not use more than directed (see overdose warning)
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- redness or swelling is present
- nervousness, dizziness, or sleeplessness occurs
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with a fever, 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 (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- do not take more than directed (see overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- mL=milliliter
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL every 4 hours
- children under 12 years of age; do not use
- Other information
- Inactive ingredients
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Principal Display Panel
Compare to the active ingredients in Theraflu® Nighttime Severe Cold & Cough*
For ages 12 & over
Nighttime
Severe Cold and COugh
Acetaminophen
Pain reliever; fever reducer
Diphenhydramine HCl
Cough suppressant; antihistamine
Phenylephrine HCl
Nasal decongestant
Alcohol 10%
Cherry Flavor
For ages 12 & over
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Nighttime Severe Cold & Cough.
- Product Label
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INGREDIENTS AND APPEARANCE
SEVERE COLD AND COUGH NIGHT TIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 55910-617 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 55910-617-08 245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/30/2015 Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
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