CALMADOL CHILDRENS- acetaminophen suspension 
Grandall Distributing Co., 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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CALMADOL CHILDRENS

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

For the reduction of fever. For the temporary relief of minor aches and pains associated with:

  • a cold
  • flu
  • headache
  • sore throat
  • toothache

Warnings

DO NOT USE

•with any other product containing acetaminophen

• for more than 3 days for fever unless directed by a doctor

• for more than 5 days for pain unless directed by a doctor

Stop Use and Ask a Doctor If:

• symptoms do not improve

• new symptoms occur· pain or fever persists or gets worse

• redness or swelling is present· sore throat is severe, lasts for more than 2 days or occurs with fever, headache, rash, nausea or vomiting

Do not exceed recommended dose:

Taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems.

Keep this and all drugs out of the reachof children. In case of accidental overdose, contact a physician or Posion Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms

TAMPER-EVIDENT BOTTLE CAP. DO NO USE IF OUTER SEAL (IMPRINT:"SEALED FOR YOUR PROTECTION") IS MISSING OR BROKEN.

This product is not manufactured or distributed by McNeil Consumer Products Co., owner of the registered trademark Children's Tylenol Elixir.

Directions

  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • Only use enclosed measuring cup
  • If needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times a day.

Weight (lb)

Age (yr)

Dose(tsp or mL)

under 24

under 2

ask a doctor

24-35

2-3

5 mL (1 tsp)

36-47

4-5

7.5 mL (1½ tsp)

48-59

6-8

10 mL (2 tsp)

60-71

9-10

12.5 mL (2½ tsp)

72-95

11

15 mL (3 tsp)

Other information:

  • Store at controlled room temperature between 15-30°C (59-86°F)

ATTENTION: This product has been specifically designed for use only with enclosed measuring cup. Use only enclosed measuring cup to dose this product Do not use any other dosing device.

Inactive ingredients

Citric Acid, Flavors, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, r ed #40, Saccharin Sodium, sodium Benzoate, Sorbitol and sucrose. Sodium Content: 1.75 mg per 5ml (t tsp)

Package Labeling

CALMADOL

CHILDRENS

ELIXIR

Alcohol Free

4 fl oz (118ml)

80 mg acetaminophen per 1/2 teaspoon

SyrupLabel

CALMADOL CHILDRENS 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48201-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48201-005-181 in 1 BOX07/08/201510/31/2016
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/08/201510/31/2016
Labeler - Grandall Distributing Co., Inc. (044428324)
Establishment
NameAddressID/FEIBusiness Operations
ALMIL Nutritional Products, Inc.153736301manufacture(48201-005)

Revised: 10/2016
Document Id: 40290cf7-9a09-177a-e054-00144ff88e88
Set id: cd724883-eb54-401e-846a-ab28f69e4141
Version: 2
Effective Time: 20161031
 
Grandall Distributing Co., Inc.